FINGERPRINT DRUG SCREENING DEVICE

Enzyme Immunoassay, Amphetamine

APPLIED TECHNOLOGY VENTURES, L.L.C.

The following data is part of a premarket notification filed by Applied Technology Ventures, L.l.c. with the FDA for Fingerprint Drug Screening Device.

Pre-market Notification Details

Device IDK973726
510k NumberK973726
Device Name:FINGERPRINT DRUG SCREENING DEVICE
ClassificationEnzyme Immunoassay, Amphetamine
Applicant APPLIED TECHNOLOGY VENTURES, L.L.C. 2190 FOX MILL RD., STE. 200 Herndon,  VA  20171
ContactRichard Roblin
CorrespondentRichard Roblin
APPLIED TECHNOLOGY VENTURES, L.L.C. 2190 FOX MILL RD., STE. 200 Herndon,  VA  20171
Product CodeDKZ  
Subsequent Product CodeDIO
Subsequent Product CodeDJG
Subsequent Product CodeLCM
Subsequent Product CodeLDJ
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-30
Decision Date1997-11-06

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