510(k) K945855 ยท GGN Plasma, Coagulation Control
A-FACT, ABNORMAL FACTOR ASSAY CONTROL
| Applicant | George King Bio-Medical, Inc., Overland Park KS, US |
| Decision | Substantially Equivalent, Oct 24, 1995 |
| Received | Nov 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945855
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.