K183555 is an FDA 510(k) clearance for the GEM Premier ChemSTAT. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on February 16, 2019, 58 days after receiving the submission on December 20, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K183555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2018 |
| Decision Date | February 16, 2019 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |