The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Doa Liquid Drugs Of Abuse Controls Levls 2,3,& 4,g2,g3,& G4.
Device ID | K940433 |
510k Number | K940433 |
Device Name: | DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 |
Classification | Drug Mixture Control Materials |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
Contact | Patricia V Willis |
Correspondent | Patricia V Willis MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
Product Code | DIF |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-31 |
Decision Date | 1994-07-20 |