ClearanceBrief
Panels › Clinical Chemistry › Product code CIC · Class 2

Cresolphthalein Complexone, Calcium

Regulation 862.1145

0510(k)s in 12 months (99 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in CIC

Company510(k)sRecalls
Em Diagnostic Systems, Inc.70
Pointe Scientific, Inc.,33
Abbott Laboratories30
American Research Products Co.30
Boehringer Mannheim Corp.30
Diagnostic Chemicals, Ltd. (Usa)30
Siemens Healthcare Diagnostics, Inc.12
Technicon Instruments Corp.30
Advanced Biomedical Methods, Inc.20
Amresco, Inc.20
Decided510(k)Device and applicantCode
May 2, 2013K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
Hitachi Chemical Diagnostics, Inc.
CIC
Mar 9, 2009K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
Siemens Healthcare Diagnostics, Inc.
CIC
Apr 26, 2007K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
Horiba Abx, FR
CIC
Mar 24, 2006K053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
Arkray, Inc.
CIC
Feb 15, 2005K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
Arkray, Inc.
CIC
Jun 25, 2004K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENT
Hemagen Diagnostics, Inc.
CIC
Mar 13, 2003K023105ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
Elan Diagnostics
CIC
Dec 21, 2001K013652WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
Wiener Laboratories Saic, AR
CIC
Apr 5, 2000K000375RANDOX CALCIUM
Randox Laboratories, Ltd., GB
CIC
May 25, 1999K991111BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
A.P. Total Care, Inc.
CIC
Jun 24, 1997K971907CALCIUM REAGENT
Carolina Liquid Chemistries Corp.
CIC
Oct 31, 1996K963292COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
Roche Diagnostic Systems, Inc.
CIC
Mar 13, 1996K955939CALCIUM REAGENT
Derma Media Lab., Inc.
CIC
Jan 5, 1995K944258CALCIUM REAGENT
Olympus America, Inc.
CIC
Feb 1, 1994K931362IL TEST CALCIUM
Instrumentation Laboratory CO
CIC
Sep 27, 1993K932158CALCIUM TEST ITEM NUMBER 65409
Em Diagnostic Systems, Inc.
CIC
Oct 19, 1992K924435OLYMPUS CALCIUM REAGENT
Olympus Corp.
CIC
Sep 15, 1992K923034MILES URINE CALCIUM METHOD
Heraeus Kulzer, Inc.
CIC
Jul 10, 1992K922233OLYMPUS CALCIUM REAGENT
Olympus Corp.
CIC
May 13, 1992K921625CALCIUM-ARSENAZO III REAGENT SET
Pointe Scientific, Inc.,
CIC
Jan 30, 1992K912027CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL
Enzyme Technology, Inc.
CIC
Jan 15, 1991K905659SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
Em Diagnostic Systems, Inc.
CIC
Oct 4, 1990K903233SYNERMED CALCIUM REAGENT KIT
Synermed, Inc., CA
CIC
Sep 13, 1990K903896CALCIUM ARSENAZO III REAGENT
Trace Scientific , Ltd., AU
CIC
Aug 17, 1990K896224COBAS READY CALCIUM REAGENT
Roche Diagnostic Systems, Inc.
CIC
Jul 17, 1990K902479CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
Amresco, Inc.
CIC
Apr 19, 1990K901226CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
Technicon Instruments Corp.
CIC
Sep 25, 1989K894407ABBOTT SPECTRUM(R) CALCIUM REAGENT
Abbott Laboratories
CIC
Sep 5, 1989K893778CALCIUM TEST ITEM NUMBER: 65409
Em Diagnostic Systems, Inc.
CIC
May 3, 1989K891217IQ CALCIUM
Bd Becton Dickinson Vacutainer Systems Preanalytic
CIC
Jan 27, 1989K884599TECHNICON RA-100 SYSTEM CALCIUM METHOD
Technicon Instruments Corp.
CIC
Jan 13, 1989K884986CALCIUM TEST ITEM NUMBER: SR1009
Em Diagnostic Systems, Inc.
CIC
Nov 29, 1988K884480BIOTROL BILIRUBIN MONOREACTIF
Biotrol, USA, Inc.
CIC
Nov 29, 1988K884433TECHNICON ASSIST(R) CALCIUM METHOD
Technicon Instruments Corp.
CIC
Aug 8, 1988K882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM
A-Kem, Inc.
CIC
May 27, 1988K880308CALCIUM
Catachem, Inc.
CIC
Apr 18, 1988K881054CALCIUM, CATALOGUE NUMBER 122-20
Diagnostic Chemicals, Ltd. (Usa), CA
CIC
Apr 5, 1988K880845CALCIUM REAGENT SET
Tech-Neal Scientific, Inc.
CIC
Feb 11, 1988K874496CALCIUM ASSAY KIT, NUMBER 120-19
Diagnostic Chemicals, Ltd. (Usa), CA
CIC
Dec 14, 1987K873519PARAMAX CALCIUM REAGENT
Baxter Healthcare Corp
CIC
Dec 4, 1987K874131CRESOLPHTHALEIN COMPLEXONE, CALCIUM
Pointe Scientific, Inc.,
CIC
Oct 2, 1987K873697MULTICHEM CALCIUM S0910
Simmler, Inc.
CIC
Oct 2, 1987K873334WAKO(TM) AUTOKIT CALCIUM
Wako Chemicals USA, Inc.
CIC
Aug 21, 1987K870362CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
Trace Scientific , Ltd., AU
CIC
Aug 18, 1987K872306SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
Boehringer Mannheim Corp.
CIC
Jun 12, 1987K871152SIGMA'S CALCIUM PROCEDURE NO. 587
Sigma Diagnostics, Inc.
CIC
May 26, 1987K871811SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
Boehringer Mannheim Corp.
CIC
Apr 29, 1987K870629CALCIUM TEST
Sclavo, Inc.
CIC
Mar 6, 1987K870170EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
Em Diagnostic Systems, Inc.
CIC
Feb 4, 1987K864661UNIFAST CALCIUM TEST
Sclavo, Inc.
CIC

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