Atlas FDA

CJE

124 FDA 510(k) clearances · Product code

44 daysmedian time to decision
131 days90th percentile
124clearances measured

FDA profile

Official device name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1050
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 1 · 2010: 3 · 2011: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Tru Liver Health Test Panel (K251074)Truvian Health2025-12-19
Alkaline Phosphatase (K240468)Abbott Laboratories Diagnostics Division2024-10-16
Alkaline Phosphatase2 (K223317)Abbott Ireland Diagnostics Division2023-07-21
Yumizen C1200 ALP, Yumizen C1200 Albumin (K191245)HORIBA ABX SAS2019-08-30
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (K171971)Lite-On Technology Corp. H.S.P.B.2018-01-25
ALP IFCC Gen.2 (K171080)Roche Diagnostics Operations (Rdo)2017-05-10
Randox RX Daytona Plus Alkaline Phosphatase (ALP) (K162275)Randox Laboratories Limited2017-04-21
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (K131351)Alfa Wassermann Diagnostic Technologies, LLC2013-08-15
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (K130141)Hitachi Chemical Diagnostics, Inc.2013-03-22
ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (K113436)Alfa Wassermann2012-07-12
ELITTECH CLINICAL SYSTEMS ALP IFCC SL (K113269)Elitechgroup2011-12-29
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS (K101090)Medica Corp.2011-05-20
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL (K073191)Thermofisher Scientific OY2008-02-28
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060205)Horiba Abx2006-07-21
COBAS INTEGRA ALP IFCC GEN.2 (K033185)Roche Diagnostics Corp.2003-10-14
MODIFICATION TO ALKP (K023807)Abbott Laboratories2002-12-26
WIENER LAB. ALP 405 (K013983)Wiener Laboratories Saic2002-01-28
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 (K012518)Thermo Dma, Inc.2001-10-09
ALKALINE PHOSPHATASE LIQUID REAGENT (K011599)Jas Diagnostics, Inc.2001-07-20
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 (K003093)Diagnostic Chemicals , Ltd.2000-11-27
ATAC PAK ALP REAGENT KIT (K002285)Elan Diagnostics2000-09-26
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H (K000067)Teco Diagnostics2000-01-20
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (K991762)A.P. Total Care, Inc.1999-09-02
ELAN ALKALINE PHOSPHATE REAGENT KIT (K991387)Elan Holdings, Inc.1999-05-19
CARESIDE ALKALINE PHOSPHATASE (K990024)Careside, Inc.1999-01-13
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE (K981897)Roche Diagnostic Systems, Inc.1998-08-26
ALKP (K981806)Abbott Laboratories1998-06-22
ALKALINE PHOSPHATASE (ALKP) (K981245)Abbott Laboratories1998-05-20
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 (K980316)Diagnostic Chemicals , Ltd.1998-02-12
LIQUID ALKALINE PHOSHATASE REAGENT SET (K973588)Pointe Scientific, Inc.,1997-10-22
ALP REAGENT SET (K971463)Carolina Liquid Chemistries Corp.1997-05-16
ALKALINE PHOSPHATASE (K964914)Derma Media Lab., Inc.1997-02-04
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 (K954840)Sigma Diagnostics, Inc.1996-02-28
ALKALINE PHOSPHATASE REAGENT SYSTEM (K952746)Medical Diagnostic Technologies, Inc.1995-11-27
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 (K951584)Sigma Diagnostics, Inc.1995-08-11
ALKALINE PHOSPHATASE (ALKP) QVET (K942997)Prisma Systems1994-12-29
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET (K941313)Stanbio Laboratory1994-05-17
EMDS ALKANINE PHOSPHATASE (ALP) TEST (K935182)Em Diagnostic Systems, Inc.1993-12-09
AMP ALKALINE PHOSPHATASE REAGENT KIT (K931986)Synermed, Inc.1993-09-08
ALKALINE PHOSPHATASE KIT (K923507)Randox Laboratories, Ltd.1992-12-03
OLYMPUS ALKALINE PHOSPHATASE REAGENT (K925156)Olympus Corp.1992-11-18
EMDS ALKALINE PHOSPHATASE (ALP) TEST (K924574)Em Diagnostic Systems, Inc.1992-11-09
OLYMPUS ALKALINE PHOSPHATASE REAGENT (K923527)Olympus Corp.1992-09-28
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 (K913921)Em Diagnostic Systems, Inc.1991-11-22
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 (K910639)Em Diagnostic Systems, Inc.1991-04-12
KINETIC ALKALINE PHOSPHATASE DETERMINATION (K905650)Biochemical Trade, Inc.1991-02-13
ALKALINE PHOSPHATASE (K905684)Amresco, Inc.1990-12-28
SYNERMED ALKALINE PHOSPHATASE REAGENT KIT (K904030)Synermed, Inc.1990-09-27
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT (K902560)Roche Diagnostic Systems, Inc.1990-07-17
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781 (K900250)American Research Products Co.1990-03-01
COULTER ALP (ALK PHOS) REAGENT (K900216)Coulter Corp.1990-02-08
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 (K895250)Em Diagnostic Systems, Inc.1989-10-31
ABBOTT CLINICAL CHEMISTRY REAGENT ALP (K890521)Abbott Laboratories1989-03-24
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 (K884549)Em Diagnostic Systems, Inc.1988-11-10
BIOTROL ALKALINE PHOSPHATASE (K881742)Biotrol, USA, Inc.1988-07-08
ALKALINE PHOSPHATASE REAGENT, DEA BUFF (K880796)Trace America, Inc.1988-04-18
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. (K880795)Trace America, Inc.1988-04-18
ALKALINE PHOSPHATASE REAGENT SET (K880307)Tech-Neal Scientific, Inc.1988-03-15
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 (K875210)Diagnostic Chemicals, Ltd. (Usa)1988-02-02
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 (K873635)Em Diagnostic Systems, Inc.1987-10-29
MULTICHEM ALKALINE PHOSPHATASE (S0903) (K873761)Simmler, Inc.1987-10-07
WAKO(TM) AUTOKIT ALP (K873333)Wako Chemicals USA, Inc.1987-10-02
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 (K873681)Em Diagnostic Systems, Inc.1987-09-29
ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. (K871543)Catachem, Inc.1987-06-22
ALKALINE PHOSPHATASE (K864905)Tech-Co, Inc.1987-01-13
U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST (K863980)U. S. Diagnostics, Inc.1986-12-04
ALKALINE PHOSPHATASE PROCEDURE (K863268)Data Medical Associates, Inc.1986-09-29
ALKALINE PHOSPHATASE TEST (K862498)King Diagnostics, Inc.1986-09-26
ALP S.C.E. (K863051)J. D. Assoc.1986-09-09
ALP (OPT) REAGENT (K862905)Sigma Diagnostics, Inc.1986-08-29
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (K862256)Sterling Diagnostics, Inc.1986-07-01
ALKALINE PHOSPHATASE PROCEDURE (K861667)Data Medical Associates, Inc.1986-05-29
KINETIC ALKALINE PHOSPHATASE REAGENT KIT (K861638)Bio-Analytics Laboratories, Inc.1986-05-29
AP REAGENT CARTRIDGE (K861284)Hi Chem, Inc.1986-04-28
ALP (ALKALINE PHOSPHATASE) REAGENT (K860715)Trace Scientific , Ltd.1986-04-24
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT (K860134)Em Diagnostic Systems, Inc.1986-02-06
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN (K852441)Clinical Data, Inc.1985-08-21
AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE (K852752)American Research Products Co.1985-07-23
ALKALINE PHOSPHATASE (K852784)Advanced Biomedical Methods, Inc.1985-07-22
ALP(ALKALINE)(PHOSPHATASE) REAGENT (K851998)Alpkem Corp.1985-05-30
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE (K850110)Abbott Laboratories1985-01-29
ALKALINE PHOSPHATASE REAGENT SET (K843332)Sterling Biochemical, Inc.1984-09-14
SYSTEMATE ALKALINE PHOSPHATASE-67203 (K843270)Em Diagnostic Systems, Inc.1984-09-13
ALKALINE PHOSPHATASE ASSAY KIT (K842243)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
SIGMA PROCED. 245 ALKALINE PHOSPHATASE (K841918)Sigma Diagnostics, Inc.1984-06-14
KINETIC ALKALINE PHOSPHATASE (K834033)American Monitor Corp.1984-01-30
ALKALINE PHOSPHATASE-RATE (K833744)Seragen Diagnostics, Inc.1984-01-13
RAICHEM ALKALINE PHOSPHATASE REAGENT (K832463)Reagents Applications, Inc.1983-09-12
PARAMAX ALKALINE PHOSPHATASE REAGENT- (K831480)American Dade1983-06-22
DATA-ZYME ALKALINE PHOSPHATASE PROCED (K831360)Data Medical Associates, Inc.1983-06-08
ALKALINE PHOSPHATASE (K823786)Analytical & Research Chemicals, Inc.1983-01-14
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI (K823213)Boehringer Mannheim Corp.1982-11-22
ULTRAZYME PLUS ALP (K821870)Harleco Diagnostics1982-07-13
ULTRAZYME PLUS ALP #64962,65029&65030 (K821471)Emd Chemicals, Inc.1982-06-02
GILCHEM ALP REAGENT (K812912)Gilford Diagnostics1981-11-02
ULTRA ZYME PLUS ALP #64962, 65029 & 30 (K812596)Harleco1981-09-29
ALKALINE PHOSPHATASE (K812452)Pointe Scientific, Inc.,1981-09-09
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT (K810082)Bio-Analytics Laboratories, Inc.1981-01-26
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO (K802574)Beckman Instruments, Inc.1980-11-12
COBAS REAGENT FOR ALKALINE PHOSPHATASE (K801242)Roche Analytical Instruments, Inc.1980-06-20
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