K884901 is an FDA 510(k) clearance for the DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on February 2, 1989, 71 days after receiving the submission on November 23, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K884901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1988 |
| Decision Date | February 02, 1989 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGN — Plasma, Coagulation Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |