ClearanceBrief
Panels › Immunology › Product code DCK · Class 2

C-Reactive Protein, Antigen, Antiserum, And Control

Regulation 866.5270

0510(k)s in 12 months (126 all time)
0recalls in 12 months (17 all time)
16recalls that name a 510(k)
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Top companies in DCK

Decided510(k)Device and applicantCode
Aug 18, 1998K982087ROCHE CRP T CONTROL N
Roche Diagnostic Systems, Inc.
DCK
Jun 12, 1998K981638IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
Beckman Coulter, Inc.
DCK
Feb 9, 1998K973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
United Biotech, Inc.
DCK
Nov 24, 1997K974050SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
Beckman Instruments, Inc.
DCK
Aug 1, 1997K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
Trinity Laboratories, Inc.
DCK
Jul 3, 1997K965110N-ASSAY TIA MULTI CRP CALIBRATOR SET
Crestat Diagnostics, Inc.
DCK
Dec 18, 1996K962049C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
Polymedco, Inc.
DCK
Nov 25, 1996K962019C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
Teco Diagnostics
DCK
Nov 4, 1996K963061IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
Beckman Instruments, Inc.
DCK
Aug 19, 1996K961829QUALITROL CRP CONTROL SET
Consolidated Technologies, Inc.
DCK
Jul 11, 1996K962373N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
Behring Diagnostics, Inc.
DCK
Jul 10, 1996K962523N LATEX CRP MONO REAGENT
Behring Diagnostics, Inc.
DCK
Apr 19, 1996K960702CRP-LATEX SEIKEN XR REAGENT SYSTEM
Globe Management Support, Inc., JP
DCK
Mar 12, 1996K960324HEMAGEN CRP 150 KIT (EIA METHOD)
Hemagen Diagnostics, Inc.
DCK
Feb 16, 1996K955156WAKO AUTOKIT CRP NEW
Wako Chemicals USA, Inc.
DCK
Dec 18, 1995K954447C-REACTIVE PROTEIN LATEX KIT
Randox Laboratories, Ltd., IE
DCK
Sep 15, 1995K953926LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
International Enzymes, Inc.
DCK
Aug 1, 1995K953207HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
The Binding Site, Ltd.
DCK
Jul 31, 1995K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
Randox Laboratories, Ltd., IE
DCK
Jul 31, 1995K953197EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
Johnson & Johnson Clinical Diagnostics, Inc.
DCK
Apr 20, 1995K951057MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
Medical Analysis Systems, Inc.
DCK
Mar 9, 1995K945280DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
Dupont Medical Products
DCK
Feb 10, 1995K946050LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2
Clinical Controls, Inc.
DCK
Oct 3, 1994K944375N/T RHEUMATOLOGY CONTROL SL/1, SL/2
Behring Diagnostics, Inc.
DCK
Oct 3, 1994K944288HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
Hemagen Diagnostics, Inc.
DCK
Mar 10, 1993K930621TINA-QUANT CRP
Boehringer Mannheim Corp.
DCK
Dec 7, 1992K924332ACCUTEX CRP LATEX TEST
J.S. Medical Assoc.
DCK
Dec 7, 1992K920845VIGIL II
Beckman Instruments, Inc.
DCK
Dec 1, 1992K923768PULSE CRP TEST
Pulse Scientific, Inc., CA
DCK
Oct 5, 1992K922722TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
Simplicity Diagnostics, Inc.
DCK
Jan 15, 1992K914155TIA CRP TEST KIT
Crestat Diagnostics, Inc.
DCK
Jul 22, 1991K905633HUMAN C-REACTIVE PROTEIN RID KIT
The Binding Site, Ltd.
DCK
Oct 1, 1990K904312RHEUMAGEN CRP T-CONTROL
Biokit USA, Inc., ES
DCK
Sep 27, 1989K895598WAKO(TM) AUTOKIT CRP
Wako Chemicals USA, Inc.
DCK
Aug 10, 1989K894573SCANLISA HUMAN CRP ELISA KIT
Immuntech A/S, DK
DCK
May 9, 1989K892526SPQ TM TEST SYSTEM II FOR CRP
Atlantic Antibodies
DCK
May 9, 1989K892198TECHNICON DPA-1 (TM) CRP METHOD
Technicon Instruments Corp.
DCK
Apr 14, 1989K892146C REACTIVE PROTEIN LIQUID
Ampcor, Inc.
DCK
Apr 14, 1989K892119QUIK-DOT C REACTIVE PROTEIN
Ampcor, Inc.
DCK
Feb 17, 1989K890423V-TREND TARGET CRP TEST
Texas Immunology, Inc.
DCK
Oct 19, 1988K884101DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DCK
Sep 7, 1988K882998ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
Amtec Diagnostics International, Inc.
DCK
Mar 30, 1988K880729KALLESTAD QM300 CALIBRATOR C PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DCK
Mar 25, 1988K880730KALLESTAD QM2/QM300 CONTROL C PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DCK
Mar 21, 1988K875345VISION(R) CRP
Abbott Laboratories
DCK
Feb 25, 1988K880016MODIFIED CRP LATEX TEST
Sclavo, Inc.
DCK
Oct 13, 1987K873865CRP
Unipath , Ltd., GB
DCK
Jun 15, 1987K871895TINA-QUANT [A] CRP
Boehringer Mannheim Corp.
DCK
May 6, 1987K871055PRECIMAT(R) CRP
Boehringer Mannheim Corp.
DCK
Mar 16, 1987K864131VISION(TM) CRP
Abbott Laboratories
DCK

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