K120681 is an FDA 510(k) clearance for the ADVIA CHEMISTRY GLUH_3 REAGENTS. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on May 15, 2012, 70 days after receiving the submission on March 6, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K120681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2012 |
| Decision Date | May 15, 2012 |
| Days to Decision | 70 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 |