K042189 is an FDA 510(k) clearance for the DIAZYME SODIUM ENZYMATIC ASSAY. This device is classified as a System, Test, Sodium, Enzymatic Method (Class II - Special Controls, product code MZU).
Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on October 7, 2004, 56 days after receiving the submission on August 12, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K042189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2004 |
| Decision Date | October 07, 2004 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MZU — System, Test, Sodium, Enzymatic Method |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |