K042191 is an FDA 510(k) clearance for the DIAZYME POTASSIUM ENZYMATIC ASSAY KIT. 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 October 29, 2004, 78 days after receiving the submission on August 12, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K042191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2004 |
| Decision Date | October 29, 2004 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| 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 |