K121558 is an FDA 510(k) clearance for the DIAZYME HSCRP POC TEST KIT. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on September 21, 2012, 115 days after receiving the submission on May 29, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K121558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2012 |
| Decision Date | September 21, 2012 |
| Days to Decision | 115 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 |