Product Code: CZW FDA class 2 21 CFR 866.5240

Complement C3, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for the detection and quantification of complement C3, the most abundant protein of the complement system and a central component in both the classical and alternative activation pathways. The kit includes antigen, antiserum, and control components for use in clinical immunology laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is CZW, regulated under 21 CFR 866.5240, within the Immunology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: CZW
Device Class: FDA class 2
Regulation Number: 866.5240
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K100179	SPAPLUS	Aug 13, 2010	Substantially Equivalent	The Binding Site Group , Ltd.
K063150	COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL	Mar 19, 2007	Substantially Equivalent	Thermo Electron OY
K061852	DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH	Sep 22, 2006	Substantially Equivalent	Dade Behring, Inc.
K050665	N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)	May 02, 2005	Substantially Equivalent	Dade Behring, Inc.
K042494	VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III	Oct 19, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics
K032796	IBL C3D-CIC EIA TEST	Jan 13, 2004	Substantially Equivalent	Ibl GmbH
K032035	SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI	Aug 07, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K012361	TINA-QUANT COMPLEMENT C3C TEST SYSTEM	Nov 29, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K010326	WAKO AUTOKIT C3	Jun 25, 2001	Substantially Equivalent	Wako Chemicals USA, Inc.
K000469	RANDOX COMPLEMENT C3	Mar 27, 2000	Substantially Equivalent	Randox Laboratories, Ltd.
K994296	DIMENSION C3 FLEX REAGENT CARTRIDGE	Mar 01, 2000	Substantially Equivalent	Dade Behring, Inc.
K981783	C3 MININEPH ANTISERUM	Dec 20, 1999	Substantially Equivalent	The Binding Site, Ltd.
K993437	K-ASSAY C3	Nov 24, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K991907	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM	Nov 09, 1999	Substantially Equivalent	Bayer Corp.
K983441	C3	Nov 04, 1998	Substantially Equivalent	Abbott Laboratories
K964298	N-ASSAY TIA MULTI V-NL	Jul 14, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K964842	IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT	Jun 11, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K962409	OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT	Oct 18, 1996	Substantially Equivalent	Olympus America, Inc.
K962199	QUANTEX C3	Sep 25, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K955857	N PROTEIN STANDARS SY	Feb 21, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K952594	N PROTEIN STANDARD SY	Jul 17, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K920007	IL TEST COMPLEMENT 3	Jun 16, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K911900	RAICHEM SPIA C3 REAGENT	May 09, 1991	Substantially Equivalent	Reagents Applications, Inc.
K902382	C3C AND C4 RID KITS	Sep 07, 1990	Substantially Equivalent	The Binding Site, Ltd.
K892127	EZ COMPLEMENT C3	Apr 14, 1989	Substantially Equivalent	Diamedix Corp.
K892125	EZ COMPLEMENT C2	Apr 14, 1989	Substantially Equivalent	Diamedix Corp.
K890675	THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4	Mar 06, 1989	Substantially Equivalent	Unipath , Ltd.
K871939	QM300 C3 ANTIBODY PACK	Jun 12, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K871024	PRECIMAT(R) C3	May 15, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K871346	DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY	Apr 21, 1987	Substantially Equivalent	Dako Corp.
K861362	IMMUNOMEDICS SERUM ELISA TEST SYSTEM	Jun 06, 1986	Substantially Equivalent	Immunomedics, Inc.
K853466	GILFORD C3 COMPLEMENT REAGENT	Sep 16, 1985	Substantially Equivalent	Gilford
K851286	RADIAL IMMUNODIFFUSION PLATES C3 & C4	Jun 05, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K850588	SPQ TEST SYSTEM FOR COMPLEMENT C3	Mar 05, 1985	Substantially Equivalent	Applications Lab
K834604	C3 ANTISERUM CONTROL	Jan 24, 1984	Substantially Equivalent	Technicon Instruments Corp.
K831905	RABBITT ANTISERUM TO HUMAN C3C	Jul 18, 1983	Substantially Equivalent	Dako Corp.
K830668	FIAX COMPLEMENT C3 TEST KIT	Apr 05, 1983	Substantially Equivalent	Intl. Diagnostic Technology
K812491	IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3	Sep 23, 1981	Substantially Equivalent	Dako Corp.
K810501	SCRIPPSYSTEM C3 RID KIT	Apr 08, 1981	Substantially Equivalent	Scripps-Miles, Inc.
K801363	COMPLEMENT C3 NEPHELOMETRIC ASSAY	Jun 30, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K800212	COMPLEMENT C3 REAGENT SYSTEM	Feb 19, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K791404	LANCER L-INA ANTI-C3	Oct 17, 1979	Substantially Equivalent	Sherwood Medical Co.
K781653	NEPHELRATE ANTISERUMS C3C	Nov 08, 1978	Substantially Equivalent	Antibodies, Inc.
K760148	SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN	Jul 20, 1976	Substantially Equivalent	Oxford Laboratories, Inc.