510(k) K043451 ยท GGN Plasma, Coagulation Control
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
| Applicant | Hyphen Biomed, Mason OH, US |
| Decision | Substantially Equivalent, Mar 17, 2005 |
| Received | Dec 14, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043451
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.