ACON LABORATORIES, INC.

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

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Filters

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

GLUCOSE OXIDASE, GLUCOSE (CGA) (5) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (5) Single (specified) analyte controls (assayed and unassayed) (JJX) (4) System, test, blood glucose, over the counter (NBW) (2)

Premarket Exempt

No Yes

Clear

On Call Plus Blood Glucose Meter - 00682607538157 Catalog Number :

Device Description : Blood Glucose Meter

Device Class : 2

Duns Number: 781100966

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 1

On Call Express Mobile Blood Glucose Monitoring System - 00682607550128 Catalog Number : 755012

Device Description : Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA, NBW, JJX

Prescription Use : No

Device Count : 1

On Call Express Mobile Blood Glucose Meter - 00682607550142 Catalog Number : 755014

Device Description : Blood Glucose Meter

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

On Call Vivid Blood Glucose Monitoring System - 00682607556113 Catalog Number :

Device Description : Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

Device Class : 1

Duns Number: 781100966

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

On Call Vivid Blood Glucose Meter - 00682607556151 Catalog Number :

Device Description : Blood Glucose Meter

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

On Call Vivid Blood Glucose Test Strips - 00682607556229 Catalog Number :

Device Description : Blood Glucose Test Strips, box of 50 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

On Call Vivid Glucose Control Solution Kit - 00682607556311 Catalog Number :

Device Description : Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

On Call Express Blood Glucose Monitoring System - 00682607557158 Catalog Number :

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JJX, NBW, CGA

Prescription Use : No

Device Count : 1

On Call Express Blood Glucose Meter - 00682607557165 Catalog Number :

Device Description : Blood Glucose Meter

Device Class : 2

Duns Number: 781100966

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

On Call Express Blood Glucose Test Strips - 00682607557295 Catalog Number :

Device Description : Blood Glucose Test Strips, box of 50 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

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