K873572 is an FDA 510(k) clearance for the IL 35260, IL TEST AMYLASE REAGENT. This device is classified as a Saccharogenic, Amylase (Class II - Special Controls, product code CIJ).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 20, 1987, 48 days after receiving the submission on September 2, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K873572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1987 |
| Decision Date | October 20, 1987 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIJ — Saccharogenic, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |