The following data is part of a premarket notification filed by Drug Screening Systems, Inc. with the FDA for Mircoline Screen For Cocaine.
| Device ID | K911652 |
| 510k Number | K911652 |
| Device Name: | MIRCOLINE SCREEN FOR COCAINE |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | DRUG SCREENING SYSTEMS, INC. 603 VPR COMMERCE CENTER P.O. BOX 579 Blackwood, NJ 08012 |
| Contact | Kenneth S Corpenter |
| Correspondent | Kenneth S Corpenter DRUG SCREENING SYSTEMS, INC. 603 VPR COMMERCE CENTER P.O. BOX 579 Blackwood, NJ 08012 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-05-15 |