K113314 is an FDA 510(k) clearance for the PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a Glucose Dehydrogenase, Glucose (Class II - Special Controls, product code LFR).
Submitted by Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW). The FDA issued a Cleared decision on November 9, 2012, 366 days after receiving the submission on November 9, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K113314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2011 |
| Decision Date | November 09, 2012 |
| Days to Decision | 366 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LFR - Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |