K073634 is an FDA 510(k) clearance for the MULTIGENT CREATININE (ENZYMATIC) ASSAY. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on June 19, 2008, 176 days after receiving the submission on December 26, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K073634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2007 |
| Decision Date | June 19, 2008 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFY - Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |