CZW · Class II · 21 CFR 866.5240

FDA Product Code CZW: Complement C3, Antigen, Antiserum, Control

Leading manufacturers include Dako Corp., Dade Behring, Inc. and Diamedix Corp..

44
Total
44
Cleared
84d
Avg days
1976
Since

FDA 510(k) Cleared Complement C3, Antigen, Antiserum, Control Devices (Product Code CZW)

44 devices
1–24 of 44
Cleared Aug 13, 2010
SPAPLUS
K100179
The Binding Site Group , Ltd.
Immunology · 204d
Cleared Sep 22, 2006
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
K061852
Dade Behring, Inc.
Immunology · 84d
Cleared May 02, 2005
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665
Dade Behring, Inc.
Immunology · 48d
Cleared Oct 19, 2004
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
K042494
Ortho-Clinical Diagnostics
Immunology · 35d
Cleared Aug 07, 2003
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
K032035
Beckman Coulter, Inc.
Immunology · 37d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361
Roche Diagnostics Corp.
Immunology · 127d
Cleared Jun 25, 2001
WAKO AUTOKIT C3
K010326
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C3
K000469
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 01, 2000
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296
Dade Behring, Inc.
Immunology · 71d
Cleared Dec 20, 1999
C3 MININEPH ANTISERUM
K981783
The Binding Site, Ltd.
Immunology · 579d
Cleared Nov 24, 1999
K-ASSAY C3
K993437
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 09, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991907
Bayer Corp.
Immunology · 155d
Cleared Nov 04, 1998
C3
K983441
Abbott Laboratories
Immunology · 35d
Cleared Jun 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842
Beckman Instruments, Inc.
Immunology · 190d
Cleared Oct 18, 1996
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409
Olympus America, Inc.
Immunology · 119d
Cleared Sep 25, 1996
QUANTEX C3
K962199
Instrumentation Laboratory CO
Immunology · 110d
Cleared Feb 21, 1996
N PROTEIN STANDARS SY
K955857
Behring Diagnostics, Inc.
Immunology · 56d
Cleared Jul 17, 1995
N PROTEIN STANDARD SY
K952594
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jun 16, 1992
IL TEST COMPLEMENT 3
K920007
Instrumentation Laboratory CO
Immunology · 166d
Cleared May 09, 1991
RAICHEM SPIA C3 REAGENT
K911900
Reagents Applications, Inc.
Immunology · 13d
Cleared Sep 07, 1990
C3C AND C4 RID KITS
K902382
The Binding Site, Ltd.
Chemistry · 100d
Cleared Apr 14, 1989
EZ COMPLEMENT C2
K892125
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
EZ COMPLEMENT C3
K892127
Diamedix Corp.
Immunology · 18d
Cleared Mar 06, 1989
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
K890675
Unipath , Ltd.
Immunology · 25d

About Product Code CZW - Regulatory Context