FDA 510(k) Applications for Medical Device Product Code "DAK"
(Complement C1q, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K012576 AMERICAN LABORATORY PRODUCTS CO., LTD. CIC-C1Q EIA 01/29/2002
K853697 BIOSTAR MEDICAL PRODUCTS, INC. BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT 12/16/1985
K861499 BIOSTAR MEDICAL PRODUCTS, INC. BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT 06/20/1986
K841541 COLLABORATIVE RESEARCH, INC. SERUM COMPLEMENT ACTIVITY TEST-SCAT 06/01/1984
K844294 CORDIS CORP. CORDIA IC 02/04/1985
K882829 CYTOTECH, INC. CIRCULATING IMMUNE COMPLEXES CONTROLS 08/04/1988
K862649 CYTOTECH, INC. CYTOTECH CIC ENZYME IMMUNOASSAY 09/04/1986
K864312 DIAMEDIX CORP. IC MICROASSAY 01/09/1987
K772003 G.D. SEARLE AND CO. HUMAN REFERENCE SERUM C4 COMPLEMENT 11/03/1977
K823009 GAMMA MEDICAL PRODUCTS, INC. GAMMA CLQ 11/05/1982
K833275 GAMMA MEDICAL PRODUCTS, INC. GMP CIQ ELISA TEST KIT 06/22/1984
K851202 GILFORD GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL 04/29/1985
K780729 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN COMPLEMENT CLQ TEST 05/18/1978
K770547 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R TM HUMAN COMPLEMENT C4 TEST 05/03/1977
K032254 IBL GMBH IBL C1Q-CIC CIA TEST 08/29/2003
K781022 ICL SCIENTIFIC ANTI-HUMAN CIQ SERUM 08/14/1978
K792472 ICL SCIENTIFIC ELECTRO-IMMUNO-QUANTITATION (EIQ) 12/27/1979
K772114 IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS FIAX C4 ASSAY 11/30/1977
K972873 IMMUNOMEDICS, INC. IMMUSTRIP HAMA IGG 03/17/1998
K770964 KALLESTAD LABORATORIES, INC. GOAT ANTISERUM COMPLEMENT C3 NEPHEL. 06/24/1977
K951968 KENT LABORATORIES, INC. HUMAN C1Q RADIAL IMMUNODIFFUSION KIT 05/30/1995
K821806 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO CLG IMMUNE COMPLEX TEST SYSTEM 06/25/1982
K821949 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* ALTERNATIVE PATHWAY COMPL. TEST 08/27/1982
K833636 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* SERUM ELISA TEST SYSTEM 06/13/1984
K973203 SANGSTAT MEDICAL CORP. THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES 09/30/1998
K860996 SCIENTIFIC SALES INTL., INC. SANASSAY IC TEST 03/30/1987
K031563 THE BINDING SITE, LTD. BINDAZYME CLQ CIC EIA KIT 09/10/2003
K914388 THE BINDING SITE, LTD. C1 RID KIT 10/28/1991


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