The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Amphetamine, Models Lkam1, Lkam5.
| Device ID | K992632 |
| 510k Number | K992632 |
| Device Name: | IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 2000-01-27 |
| Summary: | summary |