Intl. Immunoassay Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K913380	MYDAS(TM)-MB2/MYDAS(TM)-MB	JHX	1992-04-22	View
510(k)	K913349	STAMBI-CK	JHW	1991-10-23	View
510(k)	K912231	PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT	JHW	1991-07-08	View
510(k)	K903441	MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS	JHX	1990-11-06	View
510(k)	K903508	LABELLING CHANGES TO IMPRES-MB-X	JHW	1990-09-07	View
510(k)	K901450	MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB	JHT	1990-05-15	View
510(k)	K890609	IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)	CGS	1989-03-16	View
510(k)	K890543	IMPRES-MB REAGENT A AND REAGENT B	JHX	1989-03-13	View
510(k)	K883432	IMMUNOCCULT-LXI	KHE	1988-10-31	View
510(k)	K883222	ISOFOR-MM (TM)	JHW	1988-09-30	View
510(k)	K883223	CHECK-MM	JHS	1988-09-30	View
510(k)	K871143	IMMUNOCCULT EIA TEST KIT	KHE	1988-07-08	View
510(k)	K881801	IMPRES-MB	JHW	1988-06-08	View
510(k)	K881351	IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225	JHY	1988-06-01	View
510(k)	K874545	IMACK-MB TEST PROCEDURE (MODIFICATION)	JHY	1987-12-18	View
510(k)	K872598	MICROMI-CK(TM)	JHT	1987-08-03	View
510(k)	K872592	IMACK-MB(TM)	JHT	1987-07-31	View
510(k)	K843007	CARDI-CK EIA TEST KIT CK-MB ISOENZYME	JHS	1984-09-07	View
510(k)	K821963	EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.	GGP	1982-07-27	View
510(k)	K821964	125I QUICK-MB TEST KIT FOR QUANTITATION	JHT	1982-07-22	View