K864131 is an FDA 510(k) clearance for the VISION(TM) CRP. 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 March 16, 1987, 146 days after receiving the submission on October 21, 1986.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K864131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1986 |
| Decision Date | March 16, 1987 |
| Days to Decision | 146 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 |