ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A— 510(k) K071255

Clearance details

Applicant

Hyphen Biomed

Product code

Code LCO

Device class

Class 2

Regulation

21 CFR 864.7695

Advisory panel

Hematology

Date received

2007-05-04

Decision date

2007-09-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mason, OH, US

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• Z-2171-2026 — ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040AClass II·Ongoing·Aniara Diagnostica LLC·20260401
• Z-2346-2019 — ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.Class II·Terminated·Aniara Diagnostica LLC·20190719
• Z-2347-2019 — ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.Class II·Terminated·Aniara Diagnostica LLC·20190719
• Z-1742-2018 — 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 laboratories. It is intended for in vitro diagnostic use.Class II·Terminated·Hyphen BioMed·20180205
• Z-1743-2018 — 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 laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810Class II·Terminated·Hyphen BioMed·20180205
• Z-1744-2018 — 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, in human plasma, by clinical laboratories.Class II·Terminated·Hyphen BioMed·20180205
• Z-1062-2018 — 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.Class II·Terminated·Hyphen BioMed·20111109
• Z-1063-2018 — 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.Class II·Terminated·Hyphen BioMed·20111109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071255.