The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Rubella Quantitative Igg, Catalog # Lkrbq1 (100 Tests), Lkrbq5 (500 Tests).
| Device ID | K982078 |
| 510k Number | K982078 |
| Device Name: | IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) |
| 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 | 1998-06-15 |
| Decision Date | 1998-12-11 |
| Summary: | summary |