K010597 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) 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 29, 2001, 90 days after receiving the submission on February 28, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K010597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2001 |
| Decision Date | May 29, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| 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 |