K884544 is an FDA 510(k) clearance for the DADE FACTOR VIII CHROMOGENIC ASSAY. This device is classified as a Test, Qualitative And Quantitative Factor Deficiency (Class II - Special Controls, product code GGP).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on December 30, 1988, 60 days after receiving the submission on October 31, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K884544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1988 |
| Decision Date | December 30, 1988 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGP — Test, Qualitative And Quantitative Factor Deficiency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |