K904007 is an FDA 510(k) clearance for the BICARBONATE REAGENTS AMRESCO PRODUCT #4326020. This device is classified as a Enzymatic, Carbon-dioxide (Class II - Special Controls, product code KHS).
Submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on September 13, 1990, 15 days after receiving the submission on August 29, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K904007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1990 |
| Decision Date | September 13, 1990 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |