K913744 is an FDA 510(k) clearance for the IL TEST(TM) AMLYLASE. This device is classified as a Catalytic Methods, Amylase (Class II - Special Controls, product code JFJ).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 18, 1992, 182 days after receiving the submission on August 20, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K913744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1991 |
| Decision Date | February 18, 1992 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JFJ — Catalytic Methods, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |