Serono Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K953598	SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS	GKZ	1996-03-11	View
510(k)	K942051	SR1 DHEA-S ENZYME IMMUNOASSAY	JKC	1994-07-13	View
510(k)	K883085	T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS	KHQ	1988-09-09	View
510(k)	K882340	LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA	CEP	1988-08-08	View
510(k)	K880388	T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE	CDP	1988-03-03	View
510(k)	K874866	T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE	KLI	1988-02-11	View
510(k)	K873431	PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH	JLS	1987-10-20	View
510(k)	K873186	LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA	CEP	1987-09-29	View
510(k)	K873400	PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA	CFT	1987-09-25	View
510(k)	K872862	PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS	CFT	1987-09-18	View
510(k)	K873033	HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE	JHI	1987-09-14	View
510(k)	K872727	LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE	CEP	1987-08-05	View
510(k)	K872897	TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.	JLW	1987-07-31	View
510(k)	K872627	FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH	CGJ	1987-07-21	View
510(k)	K870946	MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST	LJP	1987-04-29	View
510(k)	K864565	MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT	GQH	1987-02-19	View
510(k)	K864677	TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP	JLW	1987-01-07	View
510(k)	K862813	FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT	CGJ	1986-09-16	View
510(k)	K862262	HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS	JHI	1986-07-29	View
510(k)	K861379	MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT	LKT	1986-07-16	View