K872108 is an FDA 510(k) clearance for the ABBOTT SPECTRUM BICARBONATE REAGENT KIT. 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 June 17, 1987, 16 days after receiving the submission on June 1, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K872108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1987 |
| Decision Date | June 17, 1987 |
| Days to Decision | 16 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 |