ACON LABORATORIES, INC.

Address:5850 Oberlin Drive, # 340,SAN DIEGO,CA,92121,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SYSTEM, HEMOGLOBIN, AUTOMATED (GKR) (6) Coronavirus antigen detection test system. (QKP) (2) DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) (JMT) (1) System, test, blood glucose, over the counter (NBW) (1) TEST, URINE LEUKOCYTE (LJX) (1)

Premarket Exempt

No Yes

Clear

On Call Express II Glucose Monitoring System - 00682607571147 Catalog Number : 757114

Device Description : Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 1 Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 100 lancets (30G)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Mission Plus Hemoglobin (Hb) Test Cartridges - 00682607610532 Catalog Number :

Device Description : Box of 50 Test Cartridges (5 vials)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

Mission Plus Hemoglobin (Hb) Test Cartridges - 00682607610549 Catalog Number :

Device Description : Box of 50 Test Cartridges (5 vials of 10) and 60 Capillary Transfer Tubes (3 bags of 20)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

Mission Plus Hemoglobin (Hb) Optical Verifier - 00682607610563 Catalog Number :

Device Description : Box of 2 Optical Verifiers (1 vial)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 2

Mission Plus Hemoglobin (Hb) Monitoring System - 00682607611126 Catalog Number :

Device Description : Hb Meter, vial of 2 Optical Verifiers

Device Class : 2

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

Mission Plus Hemoglobin (Hb) Monitoring System - 00682607611133 Catalog Number :

Device Description : Hb Meter, 50 Test Cartridges, 60 Capillary Transfer Tubes, 2 Optical Verifiers

Device Class : 2

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

Mission Plus Hemoglobin (Hb) Monitoring System - 00682607611140 Catalog Number :

Device Description : Hb meter, 100 Test Cartridges, 120 Capillary Transfer Tubes, 2 Optical Verifiers

Device Class : 2

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

HealthyMe UTI Urinary Tract Infection Test Strips - 00682607651009 Catalog Number :

Device Description : Urinary Tract Infection home test

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : LJX, JMT

Prescription Use : No

Device Count : 3

Flowflex COVID-19 Antigen Home Test - 00682607660261 Catalog Number : 660261

Device Description : Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : QKP

Prescription Use : No

Device Count : 1

Flowflex COVID-19 Antigen Home Test - 00682607660278 Catalog Number : 660278

Device Description : Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : QKP

Prescription Use : No

Device Count : 2

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