Hybritech, Inc.

FDA 510(k) & PMA Approved Devices — 63 products

Total Devices63

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K972666	TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY	CIN	1997-09-11	View
510(k)	K961573	TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY	CIN	1996-08-19	View
510(k)	K930810	TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY	CIN	1994-01-11	View
510(k)	K922754	TANDEM-E IGE II CALIBRATION VERIFICATION SET	JJX	1993-02-17	View
510(k)	K921745	HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO	JFH	1992-07-30	View
510(k)	K920556	TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET	JJX	1992-07-17	View
510(k)	K921252	TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL	JJX	1992-07-17	View
510(k)	K921763	TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY	JHY	1992-06-09	View
510(k)	K912439	TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET	JJX	1991-08-28	View
510(k)	K911417	ICON STREP B IMMUNOENZYMETRIC ASSAY	GTZ	1991-07-24	View
510(k)	K902991	ICON STREP B IMMUNOENZYMETRIC ASSAY	GTY	1990-10-03	View
510(k)	K895094	TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT	CEP	1989-10-31	View
510(k)	K894761	TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT	CGJ	1989-09-13	View
510(k)	K884085	TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY	JHY	1988-12-02	View
510(k)	K872131	TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY	CEP	1987-08-25	View
510(k)	K872063	TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II	JHY	1987-06-19	View
510(k)	K871235	TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT	JHI	1987-06-03	View
510(k)	K870521	TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY	JHI	1987-04-08	View
510(k)	K870520	TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY	CGJ	1987-03-10	View
510(k)	K865057	TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY	JHI	1987-03-10	View