The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Gentamicin, Models L2kge2 (200 Tests), L2kge6 (600 Tests).
| Device ID | K012311 |
| 510k Number | K012311 |
| Device Name: | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) |
| Classification | Enzyme Immunoassay, Gentamicin |
| 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 | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-08-20 |
| Summary: | summary |