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.
Device ID | K973726 |
510k Number | K973726 |
Device Name: | FINGERPRINT DRUG SCREENING DEVICE |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | APPLIED TECHNOLOGY VENTURES, L.L.C. 2190 FOX MILL RD., STE. 200 Herndon, VA 20171 |
Contact | Richard Roblin |
Correspondent | Richard Roblin APPLIED TECHNOLOGY VENTURES, L.L.C. 2190 FOX MILL RD., STE. 200 Herndon, VA 20171 |
Product Code | DKZ |
Subsequent Product Code | DIO |
Subsequent Product Code | DJG |
Subsequent Product Code | LCM |
Subsequent Product Code | LDJ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-30 |
Decision Date | 1997-11-06 |