K091455 is an FDA 510(k) clearance for the DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL. This device is classified as a Test, System, Potassium, Enzymatic Method (Class II - Special Controls, product code MZV).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on August 14, 2009, 88 days after receiving the submission on May 18, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K091455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2009 |
| Decision Date | August 14, 2009 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | MZV — Test, System, Potassium, Enzymatic Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |