K903913 is an FDA 510(k) clearance for the PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 27, 1990, 34 days after receiving the submission on August 24, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K903913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1990 |
| Decision Date | September 27, 1990 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |