K811143 is an FDA 510(k) clearance for the PH/BLOOD GAS CONTROL (ABC). This device is classified as a Controls For Blood-gases, (assayed And Unassayed) (Class I - General Controls, product code JJS).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on May 13, 1981, 16 days after receiving the submission on April 27, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K811143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1981 |
| Decision Date | May 13, 1981 |
| Days to Decision | 16 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 |