K894851 is an FDA 510(k) clearance for the TRU-TRAX. This device is classified as a Tube, Collection, Capillary Blood (Class I - General Controls, product code GIO).
Submitted by Humagen, Inc. (Charlottesville, US). The FDA issued a Cleared decision on September 29, 1989, 60 days after receiving the submission on July 31, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6150.
| 510(k) Number | K894851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1989 |
| Decision Date | September 29, 1989 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GIO — Tube, Collection, Capillary Blood |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6150 |