K854542 is an FDA 510(k) clearance for the TDX C-REACTIVE PROTEIN. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 24, 1986, 72 days after receiving the submission on November 13, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K854542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1985 |
| Decision Date | January 24, 1986 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |