Atlas FDA

CIC

99 FDA 510(k) clearances · Product code

48 daysmedian time to decision
117 days90th percentile
99clearances measured

FDA profile

Official device name
Cresolphthalein Complexone, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2009: 5 · 2010: 83 · 2011: 29 · 2012: 10 · 2016: 30 · 2018: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (K130870)Hitachi Chemical Diagnostics, Inc.2013-05-02
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (K083339)Siemens Healthcare Diagnostics, Inc.2009-03-09
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H (K070249)Horiba Abx2007-04-26
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (K053401)Arkray, Inc.2006-03-24
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (K050077)Arkray, Inc.2005-02-15
RAICHEM CALCIUM (OCPC) LIQUID REAGENT (K041009)Hemagen Diagnostics, Inc.2004-06-25
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (K023105)Elan Diagnostics2003-03-13
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (K013652)Wiener Laboratories Saic2001-12-21
RANDOX CALCIUM (K000375)Randox Laboratories, Ltd.2000-04-05
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 (K991111)A.P. Total Care, Inc.1999-05-25
CALCIUM REAGENT (K971907)Carolina Liquid Chemistries Corp.1997-06-24
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K963292)Roche Diagnostic Systems, Inc.1996-10-31
CALCIUM REAGENT (K955939)Derma Media Lab., Inc.1996-03-13
CALCIUM REAGENT (K944258)Olympus America, Inc.1995-01-05
IL TEST CALCIUM (K931362)Instrumentation Laboratory CO1994-02-01
CALCIUM TEST ITEM NUMBER 65409 (K932158)Em Diagnostic Systems, Inc.1993-09-27
OLYMPUS CALCIUM REAGENT (K924435)Olympus Corp.1992-10-19
MILES URINE CALCIUM METHOD (K923034)Heraeus Kulzer, Inc.1992-09-15
OLYMPUS CALCIUM REAGENT (K922233)Olympus Corp.1992-07-10
CALCIUM-ARSENAZO III REAGENT SET (K921625)Pointe Scientific, Inc.,1992-05-13
CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL (K912027)Enzyme Technology, Inc.1992-01-30
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 (K905659)Em Diagnostic Systems, Inc.1991-01-15
SYNERMED CALCIUM REAGENT KIT (K903233)Synermed, Inc.1990-10-04
CALCIUM ARSENAZO III REAGENT (K903896)Trace Scientific , Ltd.1990-09-13
COBAS READY CALCIUM REAGENT (K896224)Roche Diagnostic Systems, Inc.1990-08-17
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 (K902479)Amresco, Inc.1990-07-17
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) (K901226)Technicon Instruments Corp.1990-04-19
ABBOTT SPECTRUM(R) CALCIUM REAGENT (K894407)Abbott Laboratories1989-09-25
CALCIUM TEST ITEM NUMBER: 65409 (K893778)Em Diagnostic Systems, Inc.1989-09-05
IQ CALCIUM (K891217)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-05-03
TECHNICON RA-100 SYSTEM CALCIUM METHOD (K884599)Technicon Instruments Corp.1989-01-27
CALCIUM TEST ITEM NUMBER: SR1009 (K884986)Em Diagnostic Systems, Inc.1989-01-13
BIOTROL BILIRUBIN MONOREACTIF (K884480)Biotrol, USA, Inc.1988-11-29
TECHNICON ASSIST(R) CALCIUM METHOD (K884433)Technicon Instruments Corp.1988-11-29
A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (K882586)A-Kem, Inc.1988-08-08
CALCIUM (K880308)Catachem, Inc.1988-05-27
CALCIUM, CATALOGUE NUMBER 122-20 (K881054)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
CALCIUM REAGENT SET (K880845)Tech-Neal Scientific, Inc.1988-04-05
CALCIUM ASSAY KIT, NUMBER 120-19 (K874496)Diagnostic Chemicals, Ltd. (Usa)1988-02-11
PARAMAX CALCIUM REAGENT (K873519)Baxter Healthcare Corp1987-12-14
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K874131)Pointe Scientific, Inc.,1987-12-04
WAKO(TM) AUTOKIT CALCIUM (K873334)Wako Chemicals USA, Inc.1987-10-02
MULTICHEM CALCIUM S0910 (K873697)Simmler, Inc.1987-10-02
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD (K870362)Trace Scientific , Ltd.1987-08-21
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) (K872306)Boehringer Mannheim Corp.1987-08-18
SIGMA'S CALCIUM PROCEDURE NO. 587 (K871152)Sigma Diagnostics, Inc.1987-06-12
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) (K871811)Boehringer Mannheim Corp.1987-05-26
CALCIUM TEST (K870629)Sclavo, Inc.1987-04-29
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 (K870170)Em Diagnostic Systems, Inc.1987-03-06
UNIFAST CALCIUM TEST (K864661)Sclavo, Inc.1987-02-04
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K864741)Tech-Co, Inc.1987-01-09
VISION (TM) CALCIUM (K863670)Abbott Laboratories1986-11-13
CALCIUM PROCEDURE (K863256)Data Medical Associates, Inc.1986-09-26
EMDS(TM) CALCIUM TESTPACKS, #67687/95 (K863003)Em Diagnostic Systems, Inc.1986-09-16
ANALYST ANALYTICAL TEST ROTORS (K862274)E.I. Dupont DE Nemours & Co., Inc.1986-07-29
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K860664)Amresco, Inc.1986-06-27
CALCIUM PROCEDURE (K861657)Data Medical Associates, Inc.1986-05-29
A-GENT LIQUID CALCIUM (K860425)Abbott Laboratories1986-04-03
CALCIUM (CPC) REAGENT SET (K860044)Sterling Diagnostics, Inc.1986-02-11
CALCIUM LIQUID STABLE REAGENT SET (K855041)Medical Analysis Systems, Inc.1986-01-22
NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 (K854716)Nobel Scientific Industries, Inc.1986-01-07
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ (K853050)Simmler, Inc.1985-08-02
AMRESCO CALCIUM REAGENT SET (K852657)American Research Products Co.1985-07-15
CA BUFFER CA DYE (K852002)Alpkem Corp.1985-06-25
CALCIUM (K850929)Dilab, Inc.1985-06-10
CALCIUM (K850281)Boehringer Mannheim Corp.1985-02-06
CALCIUM REAGENT FOR DEMAND ANALYZER (K844241)Advanced Biomedical Methods, Inc.1985-01-03
TOTAL BILIRUBIN FOR DEMAND ANALYZER (K844243)Advanced Biomedical Methods, Inc.1985-01-03
TOTAL CALCIUM REAGENT SET (K843895)Livonia Diagnostics, Inc.1984-10-30
RAICHEM CALCIUM REAGENT (K843353)Reagents Applications, Inc.1984-09-20
SYSTEMATE CALCIUM 67214 (K843152)Em Diagnostic Systems, Inc.1984-08-29
CALCIUM ASSAY KIT (K842509)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
SERUM CALCIUM REAGENT SET (K841051)Medical Specialties, Inc.1984-05-01
FLOW-PAC CALCIUM REAGENT SET (K834336)American Research Products Co.1984-02-21
CALCIUM DYE REAGENT-CS-718-A/BUFFER (K833035)Fisher Scientific Co., LLC1983-11-03
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS (K832708)American Dade1983-10-14
SANDARE CALCIUM PROCEDURE (K832183)Sandare Chemical Co., Inc.1983-08-24
ULTRA CHEM CRESOLCAVERSACHEM #65082 (K830238)Emd Chemicals, Inc.1983-02-18
ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 (K823756)Em Industries, Inc.1983-01-12
COBAS REAGENT FOR CALCIUM (K823577)Hoffmann-La Roche, Inc.1983-01-07
LIQUIZYME CALCIUM REAGENT SET (K823219)American Research Products Co.1982-12-03
PSI CALCIUM REAGENT (K822469)Pointe Scientific, Inc.,1982-09-14
SERUM CALCIUM REAGENT SET (K821196)Omega Medical Electronics1982-07-13
WAKO CALCIUM C TEST (K820241)Wako Chemicals USA, Inc.1982-02-12
ASTRA-T CALCIUM REAGENT (K820090)Hi Chem, Inc.1982-01-28
TOTAL CALCIUM REAGENT SET (K812835)Anco Medical Reagents & Assoc.1981-10-09
GILCHEM CALCIUM REAGENT (K812110)Gilford Diagnostics1981-08-13
KING DIAGNOSTICS CALCIUM TEST (K811748)King Diagnostics, Inc.1981-07-10
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY (K802923)Beckman Instruments, Inc.1980-12-19
8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. (K802164)Panmed, Inc.1980-10-10
REAGENTS FOR DETERM. CALCIUM IN HUMAN (K800680)Diagnostic Solutions, Inc.1980-05-28
DONNECT. DIAG. CALCIUM DIAG. REAGENT (K792337)Connecticut Diagnostics, Ltd.1979-12-06
CALCIUM REAGENT SYSTEM NO. 585 (K780983)Sigma Chemical Co.1978-07-27
CALCIUM (K771831)Gamma Enterprises, Inc.1977-10-25
CALCIUM REAGENT (K771310)Mallinckrodt Critical Care1977-08-03
CENTRIFI CHEM CALCIUM REAGENT (K770460)Union Carbide Corp.1977-06-02
CALCIUM PROCEDURE, TEKPOINT DIRECT (K770449)Icn Pharmaceuticals, Inc.1977-05-03
TEST, REFORMULATED HYCEL HMA CALCIUM (K760468)Hycel, Inc.1976-11-01
REAGENT, CALCIUM DETERMINATION (K760475)Simmler & Son, Inc.1976-10-29

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