K945855 is an FDA 510(k) clearance for the A-FACT, ABNORMAL FACTOR ASSAY CONTROL. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by George King Bio-Medical, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 24, 1995, 344 days after receiving the submission on November 14, 1994.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K945855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1994 |
| Decision Date | October 24, 1995 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GGN — Plasma, Coagulation Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |