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

AUTOMATED URINALYSIS SYSTEM (KQO) (2) Coronavirus antigen detection test system. (QKP) (2)

Premarket Exempt

No Yes

Clear

Flowflex COVID-19 Antigen Home Test - 00682607660285 Catalog Number : 660285

Device Description : Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : QKP

Prescription Use : No

Device Count : 5

Flowflex COVID-19 Antigen Home Test - 00682607660476 Catalog Number : 660476

Device Description : Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : QKP

Prescription Use : No

Device Count : 25

Mission U120 Urine Analyzer - 20682607200034 Catalog Number :

Device Description : Mission U120 Urine Analyzer

Device Class : 1

Duns Number: 781100966

Premarket Exempt : No

Product Code : KQO

Prescription Use : Yes

Device Count : 1

Mission U120 Urine Analyzer - 20682607200041 Catalog Number :

Device Description : Mission U120 Urine Analyzer with Barcode Reader

Device Class : 1

Duns Number: 781100966

Premarket Exempt : No

Product Code : KQO

Prescription Use : Yes

Device Count : 1

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