CZW · Class II · 21 CFR 866.5240

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

Leading manufacturers include Dade Behring, Inc., Instrumentation Laboratory CO and Beckman Coulter, Inc..

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 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 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 Mar 01, 2000
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296
Dade Behring, Inc.
Immunology · 71d
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 Sep 25, 1996
QUANTEX C3
K962199
Instrumentation Laboratory CO
Immunology · 110d
Cleared Jun 16, 1992
IL TEST COMPLEMENT 3
K920007
Instrumentation Laboratory CO
Immunology · 166d
Cleared May 15, 1987
PRECIMAT(R) C3
K871024
Boehringer Mannheim Corp.
Immunology · 60d

About Product Code CZW - Regulatory Context