Hyphen Biomed Sasu

NEUVILLE SUR OISE Val-d'Oise, FR

HYPHEN BIOMED SASU appears in FDA device records in NEUVILLE SUR OISE Val-d'Oise, FR. FDA records list 6 510(k) clearances between 2005-03-17 and 2007-09-07, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 6
PMA records: 0
Recall records: 5
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Hyphen Biomed Sasu carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Hyphen Biomed510(k), enforcement report, recall

510(k) clearance history

FDA records hold 6 510(k) clearances for Hyphen Biomed Sasu between 2005 and 2007. The busiest year on record is 2005, with 4. The most recent is 2007, with 1.

Clearances by year, as a table

510(k) clearance decisions for Hyphen Biomed Sasu, by decision year
Year	Clearances
2005	4
2006	1
2007	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K071255	ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A	LCO	Substantially Equivalent	2007-09-07
K050367	BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6	KFF	Substantially Equivalent	2006-05-24
K050365	BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202	GGP	Substantially Equivalent	2005-12-27
K051472	BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR	GGN	Substantially Equivalent	2005-12-23
K043007	BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105	JBQ	Substantially Equivalent	2005-11-07
K043451	BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR	GGN	Substantially Equivalent	2005-03-17

Registered establishments

FDA registered establishments for Hyphen Biomed Sasu, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004434070	3004434070	HYPHEN BIOMED SASU	155 RUE D ERAGNY, NEUVILLE SUR OISE Val-d'Oise 95000 FR	2026	GGC GGN GGP GGW JBQ JCC JIT KFF LCO PPM

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
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.	Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.	Class II	2018-02-05	Terminated
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: 03663537046810	Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.	Class II	2018-02-05	Terminated
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.	Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.	Class II	2018-02-05	Terminated
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.	A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.	Class II	2011-11-09	Terminated
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.	A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.	Class II	2011-11-09	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain