K943367 is an FDA 510(k) clearance for the IL TEST CHOLINESTERASE. This device is classified as a Colorimetry, Cholinesterase (Class I - General Controls, product code DIH).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 5, 1996, 572 days after receiving the submission on July 13, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3240.
| 510(k) Number | K943367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | February 05, 1996 |
| Days to Decision | 572 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIH — Colorimetry, Cholinesterase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3240 |