The following data is part of a premarket notification filed by Diagnostic Products Corporation with the FDA for Immulite/immulite 1000, Immulite 2000 High Sensitivity Crp.
| Device ID | K063057 |
| 510k Number | K063057 |
| Device Name: | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP |
| Classification | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DIAGNOSTIC PRODUCTS CORPORATION 5210 PACIFIC CONCOURSE DR Los Angeles, CA 90045 -6900 |
| Contact | Deborah L Morris |
| Correspondent | Deborah L Morris DIAGNOSTIC PRODUCTS CORPORATION 5210 PACIFIC CONCOURSE DR Los Angeles, CA 90045 -6900 |
| Product Code | NQD |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-05 |
| Decision Date | 2006-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963792 | K063057 | 000 |
| 00630414961200 | K063057 | 000 |
| 00630414953687 | K063057 | 000 |
| 00630414953670 | K063057 | 000 |
| 00630414953144 | K063057 | 000 |