The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Tobramycn, Models L2ktc2 (2002 Tests), L2ktc6 (600 Tests).
| Device ID | K012312 |
| 510k Number | K012312 |
| Device Name: | IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) |
| Classification | Radioimmunoassay, Tobramycin |
| 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 | KLB |
| CFR Regulation Number | 862.3900 [🔎] |
| 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 |