The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite C-reactive Protein, Model Lkcr1, Lkcr5.
| Device ID | K990886 |
| 510k Number | K990886 |
| Device Name: | IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| 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 | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-17 |
| Decision Date | 1999-04-06 |
| Summary: | summary |