K951221 is an FDA 510(k) clearance for the TOTAL CO2. This device is classified as a Enzymatic, Carbon-dioxide (Class II - Special Controls, product code KHS).
Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on February 15, 1996, 332 days after receiving the submission on March 20, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K951221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1995 |
| Decision Date | February 15, 1996 |
| Days to Decision | 332 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |