Atlas FDA

CZW

44 FDA 510(k) clearances · Product code

48 daysmedian time to decision
166 days90th percentile
44clearances measured

FDA profile

Official device name
Complement C3, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5240
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
SPAPLUS (K100179)The Binding Site Group , Ltd.2010-08-13
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (K063150)Thermo Electron OY2007-03-19
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH (K061852)Dade Behring, Inc.2006-09-22
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (K050665)Dade Behring, Inc.2005-05-02
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III (K042494)Ortho-Clinical Diagnostics2004-10-19
IBL C3D-CIC EIA TEST (K032796)Ibl GmbH2004-01-13
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI (K032035)Beckman Coulter, Inc.2003-08-07
TINA-QUANT COMPLEMENT C3C TEST SYSTEM (K012361)Roche Diagnostics Corp.2001-11-29
WAKO AUTOKIT C3 (K010326)Wako Chemicals USA, Inc.2001-06-25
RANDOX COMPLEMENT C3 (K000469)Randox Laboratories, Ltd.2000-03-27
DIMENSION C3 FLEX REAGENT CARTRIDGE (K994296)Dade Behring, Inc.2000-03-01
C3 MININEPH ANTISERUM (K981783)The Binding Site, Ltd.1999-12-20
K-ASSAY C3 (K993437)Kamiya Biomedical Co.1999-11-24
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991907)Bayer Corp.1999-11-09
C3 (K983441)Abbott Laboratories1998-11-04
N-ASSAY TIA MULTI V-NL (K964298)Crestat Diagnostics, Inc.1997-07-14
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT (K964842)Beckman Instruments, Inc.1997-06-11
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT (K962409)Olympus America, Inc.1996-10-18
QUANTEX C3 (K962199)Instrumentation Laboratory CO1996-09-25
N PROTEIN STANDARS SY (K955857)Behring Diagnostics, Inc.1996-02-21
N PROTEIN STANDARD SY (K952594)Behring Diagnostics, Inc.1995-07-17
IL TEST COMPLEMENT 3 (K920007)Instrumentation Laboratory CO1992-06-16
RAICHEM SPIA C3 REAGENT (K911900)Reagents Applications, Inc.1991-05-09
C3C AND C4 RID KITS (K902382)The Binding Site, Ltd.1990-09-07
EZ COMPLEMENT C3 (K892127)Diamedix Corp.1989-04-14
EZ COMPLEMENT C2 (K892125)Diamedix Corp.1989-04-14
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 (K890675)Unipath , Ltd.1989-03-06
QM300 C3 ANTIBODY PACK (K871939)Kallestad Diag, A Div. of Erbamont, Inc.1987-06-12
PRECIMAT(R) C3 (K871024)Boehringer Mannheim Corp.1987-05-15
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY (K871346)Dako Corp.1987-04-21
IMMUNOMEDICS SERUM ELISA TEST SYSTEM (K861362)Immunomedics, Inc.1986-06-06
GILFORD C3 COMPLEMENT REAGENT (K853466)Gilford1985-09-16
RADIAL IMMUNODIFFUSION PLATES C3 & C4 (K851286)Cooper Biomedical, Inc.1985-06-05
SPQ TEST SYSTEM FOR COMPLEMENT C3 (K850588)Applications Lab1985-03-05
C3 ANTISERUM CONTROL (K834604)Technicon Instruments Corp.1984-01-24
RABBITT ANTISERUM TO HUMAN C3C (K831905)Dako Corp.1983-07-18
FIAX COMPLEMENT C3 TEST KIT (K830668)Intl. Diagnostic Technology1983-04-05
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3 (K812491)Dako Corp.1981-09-23
SCRIPPSYSTEM C3 RID KIT (K810501)Scripps-Miles, Inc.1981-04-08
COMPLEMENT C3 NEPHELOMETRIC ASSAY (K801363)J.T. Baker Chemical Co.1980-06-30
COMPLEMENT C3 REAGENT SYSTEM (K800212)Calbiochem-Behring Corp.1980-02-19
LANCER L-INA ANTI-C3 (K791404)Sherwood Medical Co.1979-10-17
NEPHELRATE ANTISERUMS C3C (K781653)Antibodies, Inc.1978-11-08
SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN (K760148)Oxford Laboratories, Inc.1976-07-20

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Every clearance here is in the API, with alerts when new ones post.