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

Biuret (Colorimetric), Total Protein

Regulation 862.1635

0510(k)s in 12 months (116 all time)
0recalls in 12 months (10 all time)
1recalls that name a 510(k)
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Top companies in CEK

Decided510(k)Device and applicantCode
Oct 18, 1999K992846HICHEM TOTAL PROTEIN REAGENT
Elan Holdings, Inc.
CEK
Mar 2, 1998K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
Diagnostic Chemicals , Ltd., CA
CEK
Feb 4, 1998K980042CARESIDE TOTAL PROTEIN
Exigent Diagnostics, Inc.
CEK
May 16, 1997K971524TOTAL PROTEIN OR TP
Carolina Liquid Chemistries Corp.
CEK
Oct 24, 1996K961864CSF/URINE TOTAL PROTEIN
Teco Diagnostics
CEK
May 30, 1996K955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
Solarcare Technologies Corp,Inc.
CEK
Mar 12, 1996K955936TOTAL PROTEIN REAGENT
Derma Media Lab., Inc.
CEK
Aug 11, 1995K950920DUPONT DIMENSION TOTAL PROTEIN METHOD
Dupont Medical Products
CEK
Jun 14, 1995K950234TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
Emd Chemicals, Inc.
CEK
May 15, 1995K950128TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
Emd Chemicals, Inc.
CEK
Dec 9, 1994K943004TOTAL PROTEIN QVET
Prisma Systems
CEK
Oct 27, 1994K941496SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY
Solarcare, Inc.
CEK
Sep 6, 1994K942424DMA MICROPROTEIN PROCEDURE
Data Medical Associates, Inc.
CEK
Apr 6, 1994K934841URINARY/CEREBROSPINAL FLUID PROTEIN
E.I. Dupont DE Nemours & Co., Inc.
CEK
Dec 16, 1993K935174TOTAL PROTEIN TEST (TPRO)
Em Diagnostic Systems, Inc.
CEK
Jan 21, 1993K921412MICROPROTEIN REAGENT SET
Sterling Diagnostics, Inc.
CEK
Dec 29, 1992K924659OLYUMPUS TOTAL PROTEIN REAGENT
Olympus Corp.
CEK
Nov 23, 1992K922467SYNCHRON TOTAL PROTEIN TEST --MODIFIED
Beckman Instruments, Inc.
CEK
Sep 9, 1992K923267SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
Em Diagnostic Systems, Inc.
CEK
Aug 12, 1992K923266NOVA TOTAL PROTEIN MODULE
Nova Biomedical Corp.
CEK
Jul 16, 1992K922361OLYMPUS TOTAL PROTEIN REAGENT
Olympus Corp.
CEK
Jul 14, 1992K920531WAKO AUTOKIT MICRO TP
Wako Chemicals USA, Inc.
CEK
Feb 18, 1992K915380MICROPROTEIN-PR
Sigma Diagnostics, Inc.
CEK
Jan 30, 1992K914885BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
Beckman Instruments, Inc.
CEK
Oct 11, 1991K913225URINE/CSF MICROPROTEIN REAGENT
Intersect Systems, Inc.
CEK
Oct 9, 1991K913978TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
Beckman Instruments, Inc.
CEK
Jul 30, 1991K912810ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
Em Diagnostic Systems, Inc.
CEK
Feb 21, 1991K905790TOTAL PROTEIN REAGENT SET
Biochemical Trade, Inc.
CEK
Jan 31, 1991K905661SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
Em Diagnostic Systems, Inc.
CEK
Jan 25, 1991K904603QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
Quantitative Medicine, Inc.
CEK
Sep 7, 1990K903511SYNERMED TOTAL PROTEIN REAGENT KIT
Synermed, Inc., CA
CEK
Jul 19, 1990K901527BIURET (COLORMETRIC), TOTAL PROTEIN
American Research Products Co.
CEK
Jul 10, 1990K900733PROTEIN TEST FOR URINE AND CSF
Elite Technology, Inc., CA
CEK
Feb 23, 1990K897166COULTER TOTAL PROTEIN REAGENT
Coulter Electronics, Inc.
CEK
Feb 16, 1990K896230COBAS READY TOTAL PROTEIN REAGENT
Roche Diagnostic Systems, Inc.
CEK
Jan 19, 1990K896916CLINISTAT TOTAL PROTEIN REAGENT TEST
Heraeus Kulzer, Inc.
CEK
Aug 31, 1989K893915EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
Em Diagnostic Systems, Inc.
CEK
May 22, 1989K890618COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
Kenlor Industries, Inc.
CEK
Mar 20, 1989K890868DMA MICROPROTEIN PROCEDURE
Data Medical Associates, Inc.
CEK
Mar 9, 1989K890278TOTAL PROTEIN REAGENT
Sigma Chemical Co.
CEK
Mar 8, 1989K890317TOTAL PROTEIN REAGENT
Medical Analysis Systems, Inc.
CEK
Jan 23, 1989K884703TOTAL PROTEIN TEST (TP) ITEM #65670
Em Diagnostic Systems, Inc.
CEK
Dec 9, 1988K884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
A-Kem, Inc.
CEK
Jul 8, 1988K881639KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
Eastman Kodak Company
CEK
Jul 1, 1988K882189BIOTROL TOTAL PROTEIN H.P.
Biotrol, USA, Inc.
CEK
Mar 24, 1988K880677TOTAL PROTEIN REAGENT SET
Tech-Neal Scientific, Inc.
CEK
Mar 24, 1988K880312WAKO(TM) AUTOKIT TOTAL PROTEIN
Wako Chemicals USA, Inc.
CEK
Jan 22, 1988K875222TOTAL PROTEIN
Catachem, Inc.
CEK
Nov 25, 1987K874476EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
Em Diagnostic Systems, Inc.
CEK
Aug 19, 1987K870371TOTAL PROTEIN REAGENT - BIURET METHOD
Trace Scientific , Ltd., AU
CEK

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