K946224 is an FDA 510(k) clearance for the CERTAIN(R) ELITE LEVEL 1, 2 AND 3. This device is classified as a Controls For Blood-gases, (assayed And Unassayed) (Class I - General Controls, product code JJS).
Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on January 30, 1995, 77 days after receiving the submission on November 14, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K946224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1994 |
| Decision Date | January 30, 1995 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJS — Controls For Blood-gases, (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |