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Immuno Concepts, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GNovember 29, 2001
K013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16November 14, 2001
K013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15November 14, 2001
K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11July 23, 1999
K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RODecember 18, 1998
K972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEMFebruary 24, 1998
K974463IMMUNO CONCEPTS ANCA TEST SYSTEMFebruary 9, 1998
K974478IMMUNO CONCEPTS ANCA TEST SYSTEMSFebruary 9, 1998
K963275RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEMSeptember 13, 1996
K955603RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEMApril 19, 1996
K955605RELISA JO-1 ANTIBODY TEST SYSTEMApril 19, 1996
K955602RELSIA SCL-70 ANTIBODY TEST SYSTEMApril 19, 1996
K955604RELISA SM/RNP ANTIBODY TEST SYSTEMApril 19, 1996
K950979HEP-2000 COLORZYME ANA-RO TEST SYSTEMJune 1, 1995
K944096HEP-2000 FLUORESCENT ANA-RO TEST SYSTEMNovember 21, 1994
K935129RELISA ENA ANTIBODY SCREENING TEST SYSTEMJanuary 31, 1994
K932225ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEMJuly 6, 1993
K911661ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEMDecember 9, 1991
K912489COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYSJuly 24, 1991
K912488FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYSJuly 24, 1991