K061093 is an FDA 510(k) clearance for the CHOLINESTERASE GEN.2 TEST SYSTEM. This device is classified as a Colorimetry, Cholinesterase (Class I - General Controls, product code DIH).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 3, 2006, 75 days after receiving the submission on April 19, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3240.
| 510(k) Number | K061093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2006 |
| Decision Date | July 03, 2006 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIH — Colorimetry, Cholinesterase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3240 |