K873520 is an FDA 510(k) clearance for the PARAMAX AMYLASE REAGENT. This device is classified as a Amyloclastic, Amylase (Class II - Special Controls, product code CJA).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on November 23, 1987, 83 days after receiving the submission on September 1, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.
| 510(k) Number | K873520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1987 |
| Decision Date | November 23, 1987 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CJA — Amyloclastic, Amylase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1070 |