DAK · Class II · 21 CFR 866.5240

FDA Product Code DAK: Complement C1q, Antigen, Antiserum, Control

Leading manufacturers include Ortho Diagnostic Systems, Inc., Biostar Medical Products, Inc. and Cytotech, Inc..

28
Total
28
Cleared
96d
Avg days
1977
Since

FDA 510(k) Cleared Complement C1q, Antigen, Antiserum, Control Devices (Product Code DAK)

28 devices
1–24 of 28
Cleared Sep 10, 2003
BINDAZYME CLQ CIC EIA KIT
K031563
The Binding Site, Ltd.
Immunology · 114d
Cleared Aug 29, 2003
IBL C1Q-CIC CIA TEST
K032254
Ibl GmbH
Immunology · 38d
Cleared Jan 29, 2002
CIC-C1Q EIA
K012576
American Laboratory Products Co., Ltd.
Immunology · 173d
Cleared Sep 30, 1998
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
K973203
Sangstat Medical Corp.
Immunology · 400d
Cleared Mar 17, 1998
IMMUSTRIP HAMA IGG
K972873
Immunomedics, Inc.
Immunology · 225d
Cleared May 30, 1995
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968
Kent Laboratories, Inc.
Immunology · 33d
Cleared Oct 28, 1991
C1 RID KIT
K914388
The Binding Site, Ltd.
Immunology · 27d
Cleared Aug 04, 1988
CIRCULATING IMMUNE COMPLEXES CONTROLS
K882829
Cytotech, Inc.
Immunology · 27d
Cleared Mar 30, 1987
SANASSAY IC TEST
K860996
Scientific Sales Intl., Inc.
Immunology · 384d
Cleared Jan 09, 1987
IC MICROASSAY
K864312
Diamedix Corp.
Immunology · 67d
Cleared Sep 04, 1986
CYTOTECH CIC ENZYME IMMUNOASSAY
K862649
Cytotech, Inc.
Immunology · 55d
Cleared Jun 20, 1986
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
K861499
Biostar Medical Products, Inc.
Immunology · 58d
Cleared Dec 16, 1985
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT
K853697
Biostar Medical Products, Inc.
Immunology · 103d
Cleared Apr 29, 1985
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
K851202
Gilford
Immunology · 34d
Cleared Feb 04, 1985
CORDIA IC
K844294
Cordis Corp.
Immunology · 90d
Cleared Jun 22, 1984
GMP CIQ ELISA TEST KIT
K833275
Gamma Medical Products, Inc.
Immunology · 275d
Cleared Jun 13, 1984
ORTHO* SERUM ELISA TEST SYSTEM
K833636
Ortho Diagnostic Systems, Inc.
Immunology · 240d
Cleared Jun 01, 1984
SERUM COMPLEMENT ACTIVITY TEST-SCAT
K841541
Collaborative Research, Inc.
Immunology · 46d
Cleared Nov 05, 1982
GAMMA CLQ
K823009
Gamma Medical Products, Inc.
Immunology · 24d
Cleared Aug 27, 1982
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949
Ortho Diagnostic Systems, Inc.
Immunology · 58d
Cleared Jun 25, 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
K821806
Ortho Diagnostic Systems, Inc.
Immunology · 8d
Cleared Dec 27, 1979
ELECTRO-IMMUNO-QUANTITATION (EIQ)
K792472
Icl Scientific
Immunology · 24d
Cleared Aug 14, 1978
ANTI-HUMAN CIQ SERUM
K781022
Icl Scientific
Immunology · 56d
Cleared May 18, 1978
LAS-R HUMAN COMPLEMENT CLQ TEST
K780729
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 16d

About Product Code DAK - Regulatory Context