Company ยท US
Hyphen Biomed
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2007. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 2007 | K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A Hyphen Biomed | LCO |
| May 24, 2006 | K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 Hyphen Biomed | KFF |
| Dec 27, 2005 | K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 Hyphen Biomed | GGP |
| Dec 23, 2005 | K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR Hyphen Biomed | GGN |
| Nov 7, 2005 | K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 Hyphen Biomed | JBQ |
| Mar 17, 2005 | K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR Hyphen Biomed | GGN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2018 | Hyphen BioMed ZYMUTEST HIA MonoStrip IgGAM.
Model Number: RK041D.
Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests. Terminated |
LCO | K071255 |
| Mar 15, 2018 | Hyphen BioMed ZYMUTEST HIA IgGAM.
Model Number: RK040D.
Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests. Terminated |
LCO | K071255 |
| Feb 5, 2018 | Hyphen BioMed ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, Terminated |
LCO | K071255 |
| Feb 5, 2018 | Hyphen BioMed ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratorie Terminated |
LCO | K071255 |
| Feb 5, 2018 | Hyphen BioMed ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical labo Terminated |
LCO | K071255 |