K030044 is an FDA 510(k) clearance for the EXTENDED RANGE HS CRP KIT, CAT NO:9200. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on September 30, 2003, 267 days after receiving the submission on January 6, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K030044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2003 |
| Decision Date | September 30, 2003 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |