The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite High Sensitivity Crp, Immulite 2000 High Sensitivity Crp.
| Device ID | K003372 |
| 510k Number | K003372 |
| Device Name: | IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP |
| Classification | System, Test, C-reactive Protein |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edwards M Levine |
| Correspondent | Edwards M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-30 |
| Decision Date | 2000-12-26 |