K901113 is an FDA 510(k) clearance for the MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Verichem Laboratories, Inc. (East Providence, US). The FDA issued a Cleared decision on March 29, 1990, 22 days after receiving the submission on March 7, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K901113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1990 |
| Decision Date | March 29, 1990 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |