K082763 is an FDA 510(k) clearance for the DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B. This device is classified as a System, Test, Sodium, Enzymatic Method (Class II - Special Controls, product code MZU).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 12, 2008, 51 days after receiving the submission on September 22, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K082763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2008 |
| Decision Date | November 12, 2008 |
| Days to Decision | 51 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | MZU — System, Test, Sodium, Enzymatic Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |