K053566 is an FDA 510(k) clearance for the MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A. This device is classified as a Test, System, Potassium, Enzymatic Method (Class II - Special Controls, product code MZV).
Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on February 15, 2006, 55 days after receiving the submission on December 22, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K053566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2005 |
| Decision Date | February 15, 2006 |
| Days to Decision | 55 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MZV — Test, System, Potassium, Enzymatic Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |