K955489 is an FDA 510(k) clearance for the CALIBRATION SERUM LEVEL 1 & 2. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 21, 1996, 207 days after receiving the submission on November 27, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K955489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 1995 |
| Decision Date | June 21, 1996 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |