K061048 is an FDA 510(k) clearance for the COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 17, 2006, 30 days after receiving the submission on April 17, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K061048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2006 |
| Decision Date | May 17, 2006 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |