K890409 is an FDA 510(k) clearance for the DADE(R) PLASMINOGEN 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 February 27, 1989, 34 days after receiving the submission on January 24, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K890409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1989 |
| Decision Date | February 27, 1989 |
| Days to Decision | 34 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 |