K945966 is an FDA 510(k) clearance for the ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on February 10, 1995, 65 days after receiving the submission on December 7, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K945966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1994 |
| Decision Date | February 10, 1995 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |