K872886 is an FDA 510(k) clearance for the CARBON DIOXIDE. This device is classified as a Phenolphthalein Colorimetry, Carbon-dioxide (Class II - Special Controls, product code KMS).
Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on August 13, 1987, 22 days after receiving the submission on July 22, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K872886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1987 |
| Decision Date | August 13, 1987 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KMS — Phenolphthalein Colorimetry, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |