510(k) K071255 ยท LCO Platelet Factor 4 Radioimmunoassay
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
| Applicant | Hyphen Biomed, Mason OH, US |
| Decision | Substantially Equivalent, Sep 7, 2007 |
| Received | May 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Aniara Diagnostica LLC ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A Open, Classified |
LCO | None listed |
| Jul 19, 2019 | Aniara Diagnostica LLC ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. Terminated |
LCO | None listed |
| Jul 19, 2019 | Aniara Diagnostica LLC ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. Terminated |
LCO | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.