K060619 is an FDA 510(k) clearance for the DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A. This device is classified as a Enzymatic, Carbon-dioxide (Class II - Special Controls, product code KHS).
Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on July 21, 2006, 135 days after receiving the submission on March 8, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K060619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2006 |
| Decision Date | July 21, 2006 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |