K874592 is an FDA 510(k) clearance for the THROMBOPLASTIN.C. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on February 4, 1988, 87 days after receiving the submission on November 9, 1987.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K874592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1987 |
| Decision Date | February 04, 1988 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GJS — Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |