K901976 is an FDA 510(k) clearance for the BLOOD GAS/CO-OXIMETRY CONTROL. This device is classified as a Controls For Blood-gases, (assayed And Unassayed) (Class I - General Controls, product code JJS).
Submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on May 31, 1990, 29 days after receiving the submission on May 2, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K901976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1990 |
| Decision Date | May 31, 1990 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJS — Controls For Blood-gases, (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |