K800681 is an FDA 510(k) clearance for the REAGENTS FOR DETERM. CO2 IN HUMAN SERUM. This device is classified as a Phenolphthalein Colorimetry, Carbon-dioxide (Class II - Special Controls, product code KMS).
Submitted by Diagnostic Solutions, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980, 65 days after receiving the submission on March 26, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K800681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1980 |
| Decision Date | May 30, 1980 |
| Days to Decision | 65 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 |