Complement C4, Antigen, Antiserum, Control

FDA product code DBI · 34 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5240
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-11-02 – 2010-09-03

DBI 2010-09-03

SPAPLUS ANALYZER

Applicant The Binding Site

K number K100455

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DBI 2001-11-29

TINA-QUANT COMPLEMENT C4 TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K012359

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DBI 2001-06-25

WAKO AUTOKIT C4

Applicant Wako Chemicals USA, Inc.

K number K010325

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DBI 2000-03-27

RANDOX COMPLEMENT C4

Applicant Randox Laboratories, Ltd.

K number K000468

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DBI 2000-03-01

DIMENSION C4 FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K994293

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DBI 1999-12-20

C4 MININEPH ANTISERUM

Applicant The Binding Site, Ltd.

K number K981785

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DBI 1999-11-29

K-ASSAY C4

Applicant Kamiya Biomedical Co.

K number K993481

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DBI 1998-11-04

C4

Applicant Abbott Laboratories

K number K983356

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DBI 1997-07-14

N-ASSAY TIA MULTI V-NL

Applicant Crestat Diagnostics, Inc.

K number K964300

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DBI 1997-07-14

N-ASSAY TIA C4 TEST KIT

Applicant Crestat Diagnostics, Inc.

K number K964297

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DBI 1996-10-18

OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT

Applicant Olympus America, Inc.

K number K962582

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DBI 1996-09-26

QUANTEX C4

Applicant Instrumentation Laboratory CO

K number K962198

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DBI 1992-03-13

IL TEST COMPLEMENT 4

Applicant Instrumentation Laboratory CO

K number K920010

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DBI 1991-05-09

RAICHEM SPIA C4 REAGENT

Applicant Reagents Applications, Inc.

K number K911899

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DBI 1989-04-14

EZ COMPLEMENT C4

Applicant Diamedix Corp.

K number K892129

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DBI 1989-02-17

SPQ(TM) ANTIBODY REAGENT SET II FOR C4

Applicant Atlantic Antibodies

K number K890564

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DBI 1988-07-08

COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM

Applicant Technicon Instruments Corp.

K number K882621

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DBI 1987-07-23

QM300 C4 ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K872599

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DBI 1987-05-14

PRECIMAT(R) C4

Applicant Boehringer Mannheim Corp.

K number K871023

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DBI 1987-03-24

TINA-QUANT(R) (A) C4

Applicant Boehringer Mannheim Corp.

K number K870931

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DBI 1986-02-26

QUANTIMETRIC PLUS C4 REAGENT KIT

Applicant Kallestad Laboratories, Inc.

K number K855012

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DBI 1985-09-16

GILFORD C4 COMPLEMENT REAGENT

Applicant Gilford

K number K853468

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DBI 1985-03-01

SPQ TEST SYSTEM FOR COMPLEMENT C4

Applicant Applications Lab

K number K850585

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DBI 1984-01-24

C4 ANTIGEN ANTIBODY CONTROL

Applicant Technicon Instruments Corp.

K number K834605

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DBI 1983-07-19

RABBIT ANTISERUM TO HUMAN C4

Applicant Dako Corp.

K number K831906

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DBI 1983-04-08

FIAX COMPLEMENT C4 TEST KIT

Applicant Intl. Diagnostic Technology

K number K830669

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DBI 1981-09-23

IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4

Applicant Dako Corp.

K number K812490

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DBI 1981-04-08

SCRIPPSYSTEM C4 RID KIT

Applicant Scripps-Miles, Inc.

K number K810502

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DBI 1980-10-31

GOAT ANTI-HUMAN COMPLEMENT C4

Applicant Protos Laboratories

K number K802196

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DBI 1980-06-30

COMPLEMENT C4 NEPHELOMETRIC ASSAY

Applicant J.T. Baker Chemical Co.

K number K801361

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DBI 1978-02-03

RADIAL IMMUNODIFFUSION KIT-COMP. 3

Applicant Gelman Instrument Co.

K number K772073

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DBI 1977-12-22

COMPLEMENT C4 NEPHELOMETRIC ASSAY

Applicant Kallestad Laboratories, Inc.

K number K772247

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DBI 1977-11-03

HUMAN C4 COMPLEMENT CONTROL SERUM

Applicant G.D. Searle and Co.

K number K772004

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DBI 1977-11-02

PLATES FOR HUMAN C4 COMPLEMENT

Applicant G.D. Searle and Co.

K number K772002

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