K884821 is an FDA 510(k) clearance for the ABBOTT SPECTRUM(R) BICARBONATE REAGENT. This device is classified as a Enzymatic, Carbon-dioxide (Class II - Special Controls, product code KHS).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on December 27, 1988, 40 days after receiving the submission on November 17, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K884821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1988 |
| Decision Date | December 27, 1988 |
| Days to Decision | 40 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 |