The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Rubella Igm,lkrm1, Lkrm2, Immulite 2000 Rubella Igm, Model L2krm2, L2krm6.
| Device ID | K012077 |
| 510k Number | K012077 |
| Device Name: | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2002-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414976716 | K012077 | 000 |
| 00630414971582 | K012077 | 000 |
| 00630414971469 | K012077 | 000 |