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CEO

105 FDA 510(k) clearances · Product code

39 daysmedian time to decision
87 days90th percentile
105clearances measured

FDA profile

Official device name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device class
Class I (low risk)
Regulation
21 CFR 862.1580
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2007: 13 · 2010: 41 · 2011: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (K100263)Seppim S.A.S.2011-05-06
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643)Beckman Coulter, Inc.2004-08-18
ATAC PAK PHOSPHORUS REAGENT (K030015)Elan Diagnostics2003-03-07
PICCOLO PHOSPHORUS TEST SYSTEM (K022312)Abaxis, Inc.2002-09-05
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (K013095)Wiener Laboratories Saic2001-11-16
PHOSPHORUS REAGENT (K003912)Jas Diagnostics, Inc.2001-02-21
RAICHEM PHOSPORUS REAGENT (K003012)Hemagen Diagnostics, Inc.2000-10-25
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867)A.P. Total Care, Inc.1999-08-02
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503)Boehringer Mannheim Corp.1998-12-01
HICHEM PHOSPHORUS REAGENT KIT (K981769)Elan Pharma, Inc.1998-06-29
CARESIDE ANALYZER (K981610)Careside, Inc.1998-06-25
PHOS (K981759)Abbott Laboratories1998-06-16
PHOS (K981118)Abbott Laboratories1998-06-12
PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 (K974858)Diagnostic Chemicals , Ltd.1998-01-30
RANDOX INORGANIC PHOSPHOROUS (K974605)Randox Laboratories, Ltd.1998-01-09
SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT (K971363)Carolina Liquid Chemistries Corp.1997-04-21
INORGANIC PHOSPHORUS REAGENT (K955937)Derma Media Lab., Inc.1996-03-12
OLYMPUS INORGANIC PHOSPHORUS REAGENT (K944768)Olympus America, Inc.1995-03-24
PHOSPHATE QVET (K942960)Prisma Systems1994-12-09
PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (K945322)Emd Chemicals, Inc.1994-12-07
PHOSPHORUS TEST (PHOS) (K945368)Emd Chemicals, Inc.1994-12-02
EMDS PHOSPHOROUS (PHOS) TEST (K935178)Em Diagnostic Systems, Inc.1993-12-17
OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT (K931835)Olympus Corp.1993-09-08
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) (K932729)Eastman Kodak Company1993-08-03
IL TEST PHOSPHORUS (K931361)Instrumentation Laboratory CO1993-05-11
OLYMPUS INORGANIC PHOSPHORUS REAGENT (K925057)Olympus Corp.1992-11-19
TWO PART INORGANIC PHOSPHORUS TEST (K924470)Em Diagnostic Systems, Inc.1992-10-14
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 (K923764)Em Diagnostic Systems, Inc.1992-09-22
OLYMPUS INORGANIC PHOSPHORUS REAGENT (K923564)Olympus Corp.1992-08-18
INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET (K915708)Tech Intl. Co.1992-01-22
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 (K912809)Em Diagnostic Systems, Inc.1991-08-12
SYNERMED PHOSPHORUS REAGENT KIT (K912569)Synermed, Inc.1991-07-17
PHOSPHORUS (INORGANIC) TEST SYSTEM (K910296)Biochemical Trade, Inc.1991-02-27
OLYMPUS INORGANIC PHOSPHORUS (K903696)Em Diagnostic Systems, Inc.1990-09-12
PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (K901964)American Research Products Co.1990-05-31
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) (K901807)Em Diagnostic Systems, Inc.1990-05-02
CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) (K901137)Technicon Instruments Corp.1990-04-12
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 (K900977)American Research Products Co.1990-04-11
COULTER PHOSPHORUS REAGENT (K900215)Coulter Corp.1990-02-08
PHOSPHORUS (K895999)American Monitor Corp.1990-01-11
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 (K890773)Hichem Diagnostics1989-04-18
IQ/QCA PHOSPHORUS (K891218)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-22
BIOTROL INORGANIC PHOSPHORUS (K885041)Biotrol, USA, Inc.1989-01-30
PHOSPHORUS TEST (PHOS) ITEM #65666 (K884735)Em Diagnostic Systems, Inc.1988-12-16
ROCHE REAGENT FOR INORGANIC PHOSPHORUS (K883962)Roche Diagnostic Systems, Inc.1988-11-29
PHOSPHORUS (INORGANIC) (K881171)Tech-Co, Inc.1988-04-28
INORGANIC PHOSPHORUS REAGENT SET (K880676)Tech-Neal Scientific, Inc.1988-03-24
KODAK EKTACHEM DT SLIDES (PHOS) (K874577)Eastman Kodak Company1988-01-21
INORGANIC PHOSPHORUS (K874472)Catachem, Inc.1987-12-22
PARAMAX PHOSPHORUS REAGENT (K873454)Baxter Healthcare Corp1987-11-23
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 (K874153)Em Diagnostic Systems, Inc.1987-11-04
MULTICHEM INORGANIC PHOSPHOROUS S0923 (K874038)Simmler, Inc.1987-10-28
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION (K870368)Trace Scientific , Ltd.1987-08-19
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS (K871321)American Research Products Co.1987-04-22
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT (K870776)Reagents Applications, Inc.1987-03-13
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 (K863718)Em Diagnostic Systems, Inc.1986-10-29
ABBOTT SPECTRUM PHOSPHORUS REAGENT (K863088)Abbott Laboratories1986-09-25
INORGANIC PHOSPHORUS PROCEDURE (K863264)Data Medical Associates, Inc.1986-09-11
FOSFOROMETER (K863072)J. D. Assoc.1986-09-09
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT (K862834)Diagnostic Chemicals, Ltd. (Usa)1986-08-19
INORGANIC PHOSPHORUS PROCEDURE (K861661)Data Medical Associates, Inc.1986-07-01
AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET (K861968)American Research Products Co.1986-06-13
INORGANIC PHOSPHORUS REAGENT SET (K860628)Sterling Diagnostics, Inc.1986-03-14
INORGANIC PHOSPHORUS REAGENT SET (K855154)Technostics Intl.1986-01-14
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO (K854188)Clinical Data, Inc.1985-11-25
PHOSPHORUS (K850934)Dilab, Inc.1985-06-25
IP ACID REAGENT IP MOLY BDATE REAGENT (K852003)Alpkem Corp.1985-05-31
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN (K852103)Medical Analysis Systems, Inc.1985-05-31
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE (K850986)Data Medical Associates, Inc.1985-04-01
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER (K850380)Advanced Biomedical Methods, Inc.1985-03-01
RAICHEM PHOSPHORUS REAGENT (K844316)Reagents Applications, Inc.1985-01-03
INORGANIC PHOSPHORUS REAGENT SET (K844182)Livonia Diagnostics, Inc.1984-11-09
INORGANIC PHOSPHORUS TEST (K843177)Sclavo, Inc.1984-09-14
SYSTEMATE PHOSPHORUS 67217 (K843330)Em Diagnostic Systems, Inc.1984-09-14
INORGANIC PHOSPHORUS ASSAY KIT (K843030)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
ASTRA SYS INORGANIC PHOSPHORUS CHEM (K841181)Beckman Instruments, Inc.1984-05-09
PHOPHORUS REAGNET SET (K841061)Medical Specialties, Inc.1984-05-01
PHOSPHORUS REAGENT SYSTEM (K840215)Sclavo, Inc.1984-03-19
PARAMAX PHOSPHORUS REAGENT (K833002)American Dade1983-10-14
COBAS REAGENT FOR INORGANIC PHOSPHORUS (K823580)Hoffmann-La Roche, Inc.1983-01-07
PHOSPHORUS REAGENT SET (K823691)Omega Medical Electronics1983-01-07
PSI INORGANIC PHOSPHORUS (K822470)Pointe Scientific, Inc.,1982-09-14
ULTRACHEM PHOS (K821874)Harleco Diagnostics1982-07-13
INORGANIC PHOSPHORUS REAGENT SET (K813400)Anco Medical Reagents & Assoc.1981-12-22
KING DIAGNOSTICS PHOSPHORUS TEST (K811749)King Diagnostics, Inc.1981-07-10
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS (K802159)Panmed, Inc.1980-10-10
REAGENT FOR DETERM. INORGANIC/PHOSPHORUS (K800690)Diagnostic Solutions, Inc.1980-05-28
SANDARE FAST 340 PHOSPHOROUS PROCEDURE (K800297)Sandare Chemical Co., Inc.1980-03-05
ELVI INORGANIC PHOSPHOROUS (K792401)Volu Sol Medical Industries1979-12-07
INORGANIC PHOSPHORUS REAGENT (K791708)Gilford Diagnostics1979-09-24
SERUM, INORGANIC PHOSPHOROUS (K790021)Fisher Scientific Co., LLC1979-02-15
REAGENT SYSTEM, INORGANIC PHOSPHORUS (K781806)Sigma Chemical Co.1979-01-17
PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS (K781000)Abbott Laboratories1978-12-04
ULTRACHEM PHOSPHORUS, 64973 (K772156)Harleco1977-12-06
INORGANIC PHOSPHORUS (K771835)Gamma Enterprises, Inc.1977-11-02
PHOSPHORUS TEST KIT (K771848)Mallinckrodt Critical Care1977-10-28
MULTISTAT III PHOSPHOROUS TEST (K771477)Instrumentation Laboratory CO1977-09-12
ULTRACHEM INORGANIC PHOSPHORUS (K770820)Harleco1977-07-11
PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT (K770456)Icn Pharmaceuticals, Inc.1977-05-03
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