K101854 is an FDA 510(k) clearance for the ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on March 7, 2011, 249 days after receiving the submission on July 1, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K101854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2010 |
| Decision Date | March 07, 2011 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |