K904461 is an FDA 510(k) clearance for the METER TRAX. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).
Submitted by Hematronix, Inc. (Plano, US). The FDA issued a Cleared decision on October 26, 1990, 25 days after receiving the submission on October 1, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K904461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1990 |
| Decision Date | October 26, 1990 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JPK — Mixture, Hematology Quality Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |