The following data is part of a premarket notification filed by Drug Screening Systems, Inc. with the FDA for Microline Screen For Methamphetamine.
Device ID | K910525 |
510k Number | K910525 |
Device Name: | MICROLINE SCREEN FOR METHAMPHETAMINE |
Classification | Thin Layer Chromatography, Amphetamine |
Applicant | DRUG SCREENING SYSTEMS, INC. 603 VPR COMMERCE CENTER P.O. BOX 579 Blackwood, NJ 08012 |
Contact | Kenneth S Carpenter |
Correspondent | Kenneth S Carpenter DRUG SCREENING SYSTEMS, INC. 603 VPR COMMERCE CENTER P.O. BOX 579 Blackwood, NJ 08012 |
Product Code | DIT |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-07 |
Decision Date | 1991-04-05 |