Isolab, Inc.

FDA 510(k) & PMA Approved Devices — 44 products

Total Devices44

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K951014	ISOLAB'S T4 TEST KIT	KLI	1996-10-18	View
510(k)	K950481	NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT	JIA	1996-02-01	View
510(k)	K943547	PHENYLALANINE TEST KIT	JNB	1996-01-26	View
510(k)	K950803	ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE	JJT	1995-09-21	View
510(k)	K950415	FLUOROSCAN NEONATAL	KHO	1995-09-05	View
510(k)	K942222	QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS	JCM	1995-01-20	View
510(k)	K942276	QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY	GIQ	1995-01-20	View
510(k)	K944185	ISOSCAN	JQT	1994-11-17	View
510(k)	K934013	RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT	CIN	1994-04-26	View
510(k)	K923153	HEMOCARD, HEMOGLOBIN C ASSAY	MLL	1994-01-27	View
510(k)	K931234	HEMOCARD CONTROL HB-AA, AE, FAA, FAE	JCM	1993-05-11	View
510(k)	K930070	HEMOCARD HEMOGLOBIN E	CKA	1993-04-08	View
510(k)	K924173	HEMOCARD(TM) CONTROL	JCM	1992-12-01	View
510(k)	K921681	CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL	GGM	1992-11-17	View
510(k)	K911981	HEMOCARD HEMOGLOBIN S	GHM	1991-10-09	View
510(k)	K910430	HEMOCARD-AS	GHM	1991-04-15	View
510(k)	K910431	HEMOCARD CONTROL	JCM	1991-03-11	View
510(k)	K905513	GLYC-AFFIN(TM)-GA	LCP	1991-01-15	View
510(k)	K904814	GLYC-AFFIN GP	LCP	1990-12-26	View
510(k)	K902740	LDL-DIRECT CONTROLS	JJY	1990-12-07	View