Atlas FDA

DBI

34 FDA 510(k) clearances · Product code

45 daysmedian time to decision
198 days90th percentile
34clearances measured

FDA profile

Official device name
Complement C4, 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 ANALYZER (K100455)The Binding Site2010-09-03
TINA-QUANT COMPLEMENT C4 TEST SYSTEM (K012359)Roche Diagnostics Corp.2001-11-29
WAKO AUTOKIT C4 (K010325)Wako Chemicals USA, Inc.2001-06-25
RANDOX COMPLEMENT C4 (K000468)Randox Laboratories, Ltd.2000-03-27
DIMENSION C4 FLEX REAGENT CARTRIDGE (K994293)Dade Behring, Inc.2000-03-01
C4 MININEPH ANTISERUM (K981785)The Binding Site, Ltd.1999-12-20
K-ASSAY C4 (K993481)Kamiya Biomedical Co.1999-11-29
C4 (K983356)Abbott Laboratories1998-11-04
N-ASSAY TIA C4 TEST KIT (K964297)Crestat Diagnostics, Inc.1997-07-14
N-ASSAY TIA MULTI V-NL (K964300)Crestat Diagnostics, Inc.1997-07-14
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT (K962582)Olympus America, Inc.1996-10-18
QUANTEX C4 (K962198)Instrumentation Laboratory CO1996-09-26
IL TEST COMPLEMENT 4 (K920010)Instrumentation Laboratory CO1992-03-13
RAICHEM SPIA C4 REAGENT (K911899)Reagents Applications, Inc.1991-05-09
EZ COMPLEMENT C4 (K892129)Diamedix Corp.1989-04-14
SPQ(TM) ANTIBODY REAGENT SET II FOR C4 (K890564)Atlantic Antibodies1989-02-17
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM (K882621)Technicon Instruments Corp.1988-07-08
QM300 C4 ANTIBODY PACK (K872599)Kallestad Diag, A Div. of Erbamont, Inc.1987-07-23
PRECIMAT(R) C4 (K871023)Boehringer Mannheim Corp.1987-05-14
TINA-QUANT(R) (A) C4 (K870931)Boehringer Mannheim Corp.1987-03-24
QUANTIMETRIC PLUS C4 REAGENT KIT (K855012)Kallestad Laboratories, Inc.1986-02-26
GILFORD C4 COMPLEMENT REAGENT (K853468)Gilford1985-09-16
SPQ TEST SYSTEM FOR COMPLEMENT C4 (K850585)Applications Lab1985-03-01
C4 ANTIGEN ANTIBODY CONTROL (K834605)Technicon Instruments Corp.1984-01-24
RABBIT ANTISERUM TO HUMAN C4 (K831906)Dako Corp.1983-07-19
FIAX COMPLEMENT C4 TEST KIT (K830669)Intl. Diagnostic Technology1983-04-08
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 (K812490)Dako Corp.1981-09-23
SCRIPPSYSTEM C4 RID KIT (K810502)Scripps-Miles, Inc.1981-04-08
GOAT ANTI-HUMAN COMPLEMENT C4 (K802196)Protos Laboratories1980-10-31
COMPLEMENT C4 NEPHELOMETRIC ASSAY (K801361)J.T. Baker Chemical Co.1980-06-30
RADIAL IMMUNODIFFUSION KIT-COMP. 3 (K772073)Gelman Instrument Co.1978-02-03
COMPLEMENT C4 NEPHELOMETRIC ASSAY (K772247)Kallestad Laboratories, Inc.1977-12-22
HUMAN C4 COMPLEMENT CONTROL SERUM (K772004)G.D. Searle and Co.1977-11-03
PLATES FOR HUMAN C4 COMPLEMENT (K772002)G.D. Searle and Co.1977-11-02

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