K965110 is an FDA 510(k) clearance for the N-ASSAY TIA MULTI CRP CALIBRATOR SET. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on July 3, 1997, 195 days after receiving the submission on December 20, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K965110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1996 |
| Decision Date | July 03, 1997 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |