The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Cocaine Metabolite.
| Device ID | K963918 |
| 510k Number | K963918 |
| Device Name: | IMMULITE COCAINE METABOLITE |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine, Ph.d. |
| Correspondent | Edward M Levine, Ph.d. DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1997-04-08 |
| Summary: | summary |