Atlas FDA

CEK

116 FDA 510(k) clearances · Product code

49 daysmedian time to decision
153 days90th percentile
116clearances measured

FDA profile

Official device name
Biuret (Colorimetric), Total Protein
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1635
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2002: 1 · 2010: 8 · 2011: 10 · 2024: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HICHEM TOTAL PROTEIN REAGENT (K992846)Elan Holdings, Inc.1999-10-18
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (K973108)Diagnostic Chemicals , Ltd.1998-03-02
CARESIDE TOTAL PROTEIN (K980042)Exigent Diagnostics, Inc.1998-02-04
TOTAL PROTEIN OR TP (K971524)Carolina Liquid Chemistries Corp.1997-05-16
CSF/URINE TOTAL PROTEIN (K961864)Teco Diagnostics1996-10-24
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (K955905)Solarcare Technologies Corp,Inc.1996-05-30
TOTAL PROTEIN REAGENT (K955936)Derma Media Lab., Inc.1996-03-12
DUPONT DIMENSION TOTAL PROTEIN METHOD (K950920)Dupont Medical Products1995-08-11
TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (K950234)Emd Chemicals, Inc.1995-06-14
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (K950128)Emd Chemicals, Inc.1995-05-15
TOTAL PROTEIN QVET (K943004)Prisma Systems1994-12-09
SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (K941496)Solarcare, Inc.1994-10-27
DMA MICROPROTEIN PROCEDURE (K942424)Data Medical Associates, Inc.1994-09-06
URINARY/CEREBROSPINAL FLUID PROTEIN (K934841)E.I. Dupont DE Nemours & Co., Inc.1994-04-06
TOTAL PROTEIN TEST (TPRO) (K935174)Em Diagnostic Systems, Inc.1993-12-16
MICROPROTEIN REAGENT SET (K921412)Sterling Diagnostics, Inc.1993-01-21
OLYUMPUS TOTAL PROTEIN REAGENT (K924659)Olympus Corp.1992-12-29
SYNCHRON TOTAL PROTEIN TEST --MODIFIED (K922467)Beckman Instruments, Inc.1992-11-23
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 (K923267)Em Diagnostic Systems, Inc.1992-09-09
NOVA TOTAL PROTEIN MODULE (K923266)Nova Biomedical Corp.1992-08-12
OLYMPUS TOTAL PROTEIN REAGENT (K922361)Olympus Corp.1992-07-16
WAKO AUTOKIT MICRO TP (K920531)Wako Chemicals USA, Inc.1992-07-14
MICROPROTEIN-PR (K915380)Sigma Diagnostics, Inc.1992-02-18
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST (K914885)Beckman Instruments, Inc.1992-01-30
URINE/CSF MICROPROTEIN REAGENT (K913225)Intersect Systems, Inc.1991-10-11
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE (K913978)Beckman Instruments, Inc.1991-10-09
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 (K912810)Em Diagnostic Systems, Inc.1991-07-30
TOTAL PROTEIN REAGENT SET (K905790)Biochemical Trade, Inc.1991-02-21
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 (K905661)Em Diagnostic Systems, Inc.1991-01-31
QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM (K904603)Quantitative Medicine, Inc.1991-01-25
SYNERMED TOTAL PROTEIN REAGENT KIT (K903511)Synermed, Inc.1990-09-07
BIURET (COLORMETRIC), TOTAL PROTEIN (K901527)American Research Products Co.1990-07-19
PROTEIN TEST FOR URINE AND CSF (K900733)Elite Technology, Inc.1990-07-10
COULTER TOTAL PROTEIN REAGENT (K897166)Coulter Electronics, Inc.1990-02-23
COBAS READY TOTAL PROTEIN REAGENT (K896230)Roche Diagnostic Systems, Inc.1990-02-16
CLINISTAT TOTAL PROTEIN REAGENT TEST (K896916)Heraeus Kulzer, Inc.1990-01-19
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 (K893915)Em Diagnostic Systems, Inc.1989-08-31
COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT (K890618)Kenlor Industries, Inc.1989-05-22
DMA MICROPROTEIN PROCEDURE (K890868)Data Medical Associates, Inc.1989-03-20
TOTAL PROTEIN REAGENT (K890278)Sigma Chemical Co.1989-03-09
TOTAL PROTEIN REAGENT (K890317)Medical Analysis Systems, Inc.1989-03-08
TOTAL PROTEIN TEST (TP) ITEM #65670 (K884703)Em Diagnostic Systems, Inc.1989-01-23
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (K884225)A-Kem, Inc.1988-12-09
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) (K881639)Eastman Kodak Company1988-07-08
BIOTROL TOTAL PROTEIN H.P. (K882189)Biotrol, USA, Inc.1988-07-01
WAKO(TM) AUTOKIT TOTAL PROTEIN (K880312)Wako Chemicals USA, Inc.1988-03-24
TOTAL PROTEIN REAGENT SET (K880677)Tech-Neal Scientific, Inc.1988-03-24
TOTAL PROTEIN (K875222)Catachem, Inc.1988-01-22
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 (K874476)Em Diagnostic Systems, Inc.1987-11-25
TOTAL PROTEIN REAGENT - BIURET METHOD (K870371)Trace Scientific , Ltd.1987-08-19
MULTICHEM TOTAL PROTEIN REAGENT #S0928 (K871975)Simmler, Inc.1987-06-05
BIURET (COLORIMETRIC), TOTAL PROTEIN (K864743)Tech-Co, Inc.1987-01-13
TOTAL PROTEIN PROCEDURE (K863258)Data Medical Associates, Inc.1986-09-29
DEMAND TOTAL PROTEIN (K863301)Cooper Biomedical, Inc.1986-09-26
TOTAL PROTEINS (K863074)J. D. Assoc.1986-09-09
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 (K863005)Em Diagnostic Systems, Inc.1986-08-29
WAKO MICRO TP (K861508)Wako Chemicals USA, Inc.1986-08-19
VISION TOTAL PROTEIN (K861798)Abbott Laboratories1986-06-17
TOTAL PROTEIN PROCEDURE (K861663)Data Medical Associates, Inc.1986-06-13
EASY-TEST TOTAL PROTEIN (TP), #67513/93 (K860917)Em Diagnostic Systems, Inc.1986-04-07
A-GENT LIQUID TOTAL PROTEIN (K860426)Abbott Laboratories1986-04-03
TOTAL PROTEIN (BIURET) REAGENT SET (K860341)Sterling Diagnostics, Inc.1986-02-11
NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 (K854717)Nobel Scientific Industries, Inc.1986-01-14
TOTAL PROTEIN REAGENT SET (K855191)Technostics Intl.1986-01-14
QUANTTEST TOTAL PROTEIN ASSAY (K853932)Quantimetrix Corp.1985-12-19
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT (K853930)Quantimetrix Corp.1985-12-10
TOTAL PROTEIN (K854553)American Monitor Corp.1985-11-25
SIGMA 610 FOR PROTEIN IN URINE & CSF (K853681)Sigma Diagnostics, Inc.1985-10-28
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE (K853244)Simmler, Inc.1985-08-12
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC (K852844)American Research Products Co.1985-07-22
TOTAL PROTEINS (K850936)Dilab, Inc.1985-06-25
TP BIURET REAGENT (K852006)Alpkem Corp.1985-06-10
TOTAL PROTEIN LIQUID STABLE REAGENT SET (K851877)Medical Analysis Systems, Inc.1985-05-20
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER (K844331)Advanced Biomedical Methods, Inc.1985-01-03
TOTAL PROTEIN REAGENT SET (K843701)Livonia Diagnostics, Inc.1984-10-01
TOTAL PROTEIN ASSAY KIT (K843028)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
SYSTEMATE TOTAL PROTEIN 67218 (K843107)Em Diagnostic Systems, Inc.1984-08-27
TOTAL PROTEIN REAGENT BIURET (K841466)Reagents Applications, Inc.1984-05-16
SERUM TOTAL PROTEIN REAGENT SET (K841069)Medical Specialties, Inc.1984-05-01
PARAMAX TOTAL PROTEIN REAGENT TP (K845052)American Dade1984-04-13
MCS TOTAL PROTEIN REAGENT (K840290)Medilab Corp.1984-03-30
TOTAL PROTEIN REAGENT CS-724 (K833950)Fisher Scientific Co., LLC1984-01-13
TOTAL PROTEIN PROCEDURE (K832169)Sandare Chemical Co., Inc.1983-08-16
FLOW-PAC TOTAL PROTEIN REAGENT SET (K830538)Amresco, Inc.1983-03-24
COBAS REAGENT FOR TOTAL PROTEIN (K823579)Hoffmann-La Roche, Inc.1983-01-07
LIQUIZYME TOTAL PROTEIN REAGENT (K823170)Amresco, Inc.1982-11-29
PSI TOTAL PROTEIN REAGENT (K822468)Pointe Scientific, Inc.,1982-09-14
BIURET (COLORIMETRIC) TOTAL PROTEIN (K821905)American Monitor Corp.1982-07-20
SERUM TOTAL PROTEIN REAGENT SET (K821210)Omega Medical Electronics1982-07-13
RA-1000 SYSTEM ADD'L ANALYTES PHASE III (K820913)Technicon Instruments Corp.1982-05-03
ASTRA TOTAL PROTEIN REAGENT (K813536)Hi Chem, Inc.1981-12-31
TOTAL PROTEIN REAGENT SET (K812833)Anco Medical Reagents & Assoc.1981-11-27
ULTRACHEM TP, ITEM #64974 (K813038)Harleco1981-11-10
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) (K812028)Eastman Kodak Company1981-08-03
TOTAL PROTEIN TEST (K811673)King Diagnostics, Inc.1981-06-25
IL TOTAL PROTEIN REAGENT (K802310)Instrumentation Laboratory CO1980-10-23
BIURET REAGENT & TOTAL PROTEIN BLANK SOL (K802161)Panmed, Inc.1980-10-10
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM (K801749)Beckman Instruments, Inc.1980-09-16
TOTAL PROTEIN TEST (K801061)Environmental Chemical Specialties1980-07-21
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (K800674)Diagnostic Solutions, Inc.1980-05-28
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