K990704 is an FDA 510(k) clearance for the ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 3, 1999, 60 days after receiving the submission on March 4, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K990704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1999 |
| Decision Date | May 03, 1999 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |