K770942 is an FDA 510(k) clearance for the PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977, 58 days after receiving the submission on May 24, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K770942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1977 |
| Decision Date | July 21, 1977 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |