AK GLOBALTECH CORP

Address:21 Grand Ave Ste 102,Palisades Park,NJ,07650,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

Blood Alcohol Kit (Excludes Hiv Testing) (OIC) (10) Devices, Breath Trapping, Alcohol (DJZ) (10)

Premarket Exempt

Yes

Clear

AlcoMate - 00684079997852 Catalog Number : AKG INDMP

Device Description : AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Diffe

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693033 Catalog Number : AKG STMP20

Device Description : AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Diffe

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693040 Catalog Number : AKG STMP250

Device Description : AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Diffe

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693057 Catalog Number : AKG STMP500

Device Description : AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Diffe

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693064 Catalog Number : AKG STMP1000

Device Description : AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Diffe

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693071 Catalog Number : AKG SM600

Device Description : Fuel-Cell technology provides you with increased precision and accuracy, and als

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693095 Catalog Number : AKG STMP100

Device Description : AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Diffe

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693118 Catalog Number : AKG AL4000

Device Description : AlcoMate AL4000 FUEL CELL Coin-Operated Vending-Type Breathalyzer with Pre-Calib

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoMate - 00686091693125 Catalog Number : AKG AL2500 Elite

Device Description : The AL2500 Elite breathalyzer is a convenient, easy-to-use breathalyzer that use

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

AlcoScan - 00686091998336 Catalog Number : AKG SM3100

Device Description : SM3100 uses an Oxide Semiconductor sensor for high volume testing. The sensor mo

Device Class : 1

Duns Number: 119201320

Premarket Exempt : Yes

Product Code : OIC, DJZ

Prescription Use : No

Device Count : 1

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