Intl. Immunoassay Laboratories, Inc. - FDA 510(k) Cleared Devices
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intl. Immunoassay Laboratories, Inc. Chemistry ✕
24 devices
Cleared
Apr 22, 1992
MYDAS(TM)-MB2/MYDAS(TM)-MB
Chemistry
268d
Cleared
Oct 23, 1991
STAMBI-CK
Chemistry
89d
Cleared
Jul 08, 1991
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
Chemistry
49d
Cleared
Nov 06, 1990
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
Chemistry
98d
Cleared
Sep 07, 1990
LABELLING CHANGES TO IMPRES-MB-X
Chemistry
38d
Cleared
May 15, 1990
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
Chemistry
48d
Cleared
Mar 16, 1989
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
Chemistry
37d
Cleared
Mar 13, 1989
IMPRES-MB REAGENT A AND REAGENT B
Chemistry
38d
Cleared
Sep 30, 1988
ISOFOR-MM (TM)
Chemistry
63d
Cleared
Sep 30, 1988
CHECK-MM
Chemistry
63d
Cleared
Jun 08, 1988
IMPRES-MB
Chemistry
42d
Cleared
Jun 01, 1988
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
Chemistry
63d
Cleared
Dec 18, 1987
IMACK-MB TEST PROCEDURE (MODIFICATION)
Chemistry
45d
Cleared
Aug 03, 1987
MICROMI-CK(TM)
Chemistry
32d
Cleared
Jul 31, 1987
IMACK-MB(TM)
Chemistry
30d
Cleared
Sep 07, 1984
CARDI-CK EIA TEST KIT CK-MB ISOENZYME
Chemistry
38d
Cleared
Jul 22, 1982
125I QUICK-MB TEST KIT FOR QUANTITATION
Chemistry
21d
Cleared
Dec 22, 1981
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
Chemistry
43d
Cleared
Dec 17, 1981
ANDRIA-FSH RIA TEST KIT
Chemistry
45d
Cleared
Dec 17, 1981
ABURIA-CK RIA TEST KIT
Chemistry
45d
Cleared
Oct 02, 1981
EMBRITROL CK-MB CONTROLS
Chemistry
11d
Cleared
Aug 13, 1981
MARRIA-HPRL RIA KIT
Chemistry
17d
Cleared
Apr 29, 1981
125 I-T4 RIA TEST KIT
Chemistry
9d
Cleared
Sep 26, 1980
EMBRIA-CK
Chemistry
64d