510(k) K051472 ยท GGN Plasma, Coagulation Control
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
| Applicant | Hyphen Biomed, Mason OH, US |
| Decision | Substantially Equivalent, Dec 23, 2005 |
| Received | Jun 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2022 | Aniara Diagnostica LLC BIOPHEN UFH Control Plasma Terminated |
GGN | None listed |
| Mar 19, 2019 | Aniara Diagnostica LLC BIOPHEN UFH Control C2, REF 223901 Terminated |
GGN | None listed |
| Mar 19, 2019 | Aniara Diagnostica LLC BIOPHEN UFH Control C1, REF 224101 Terminated |
GGN | None listed |
| Mar 19, 2019 | Aniara Diagnostica LLC BIOPHEN LMWH Control C4, REF 224201 Terminated |
GGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.