K103788 is an FDA 510(k) clearance for the PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on November 8, 2011, 316 days after receiving the submission on December 27, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K103788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2010 |
| Decision Date | November 08, 2011 |
| Days to Decision | 316 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 |