K091216 is an FDA 510(k) clearance for the CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797. This device is classified as a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II - Special Controls, product code JIL).
Submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on October 9, 2009, 165 days after receiving the submission on April 27, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1340.
| 510(k) Number | K091216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2009 |
| Decision Date | October 09, 2009 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1340 |