Product code CEK— Clinical Chemistry
TOTAL PROTEIN REAGENT SET
- Classification name
- Biuret (Colorimetric), Total Protein
- Device class
- Class 2
- Regulation
- 21 CFR 862.1635
- Advisory panel
- Clinical Chemistry
- Total cleared
- 116
- First cleared
- Most recent
Market context for product code CEK
FDA has cleared devices under product code CEK between 1976 and 1999, filed by 78 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
Top applicants under product code CEK
Recent clearances under product code CEK
1–100 of 116- K992846 — HICHEM TOTAL PROTEIN REAGENT
- K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
- K980042 — CARESIDE TOTAL PROTEIN
- K971524 — TOTAL PROTEIN OR TP
- K961864 — CSF/URINE TOTAL PROTEIN
- K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
- K955936 — TOTAL PROTEIN REAGENT
- K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD
- K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
- K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
- K943004 — TOTAL PROTEIN QVET
- K941496 — SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY
- K942424 — DMA MICROPROTEIN PROCEDURE
- K934841 — URINARY/CEREBROSPINAL FLUID PROTEIN
- K935174 — TOTAL PROTEIN TEST (TPRO)
- K921412 — MICROPROTEIN REAGENT SET
- K924659 — OLYUMPUS TOTAL PROTEIN REAGENT
- K922467 — SYNCHRON TOTAL PROTEIN TEST --MODIFIED
- K923267 — SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
- K923266 — NOVA TOTAL PROTEIN MODULE
- K922361 — OLYMPUS TOTAL PROTEIN REAGENT
- K920531 — WAKO AUTOKIT MICRO TP
- K915380 — MICROPROTEIN-PR
- K914885 — BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
- K913225 — URINE/CSF MICROPROTEIN REAGENT
- K913978 — TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
- K912810 — ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
- K905790 — TOTAL PROTEIN REAGENT SET
- K905661 — SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
- K904603 — QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
- K903511 — SYNERMED TOTAL PROTEIN REAGENT KIT
- K901527 — BIURET (COLORMETRIC), TOTAL PROTEIN
- K900733 — PROTEIN TEST FOR URINE AND CSF
- K897166 — COULTER TOTAL PROTEIN REAGENT
- K896230 — COBAS READY TOTAL PROTEIN REAGENT
- K896916 — CLINISTAT TOTAL PROTEIN REAGENT TEST
- K893915 — EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
- K890618 — COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
- K890868 — DMA MICROPROTEIN PROCEDURE
- K890278 — TOTAL PROTEIN REAGENT
- K890317 — TOTAL PROTEIN REAGENT
- K884703 — TOTAL PROTEIN TEST (TP) ITEM #65670
- K884225 — TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
- K881639 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
- K882189 — BIOTROL TOTAL PROTEIN H.P.
- K880312 — WAKO(TM) AUTOKIT TOTAL PROTEIN
- K880677 — TOTAL PROTEIN REAGENT SET
- K875222 — TOTAL PROTEIN
- K874476 — EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
- K870371 — TOTAL PROTEIN REAGENT - BIURET METHOD
- K871975 — MULTICHEM TOTAL PROTEIN REAGENT #S0928
- K864743 — BIURET (COLORIMETRIC), TOTAL PROTEIN
- K863258 — TOTAL PROTEIN PROCEDURE
- K863301 — DEMAND TOTAL PROTEIN
- K863074 — TOTAL PROTEINS
- K863005 — EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
- K861508 — WAKO MICRO TP
- K861798 — VISION TOTAL PROTEIN
- K861663 — TOTAL PROTEIN PROCEDURE
- K860917 — EASY-TEST TOTAL PROTEIN (TP), #67513/93
- K860426 — A-GENT LIQUID TOTAL PROTEIN
- K860341 — TOTAL PROTEIN (BIURET) REAGENT SET
- K854717 — NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928
- K855191 — TOTAL PROTEIN REAGENT SET
- K853932 — QUANTTEST TOTAL PROTEIN ASSAY
- K853930 — QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT
- K854553 — TOTAL PROTEIN
- K853681 — SIGMA 610 FOR PROTEIN IN URINE & CSF
- K853244 — TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
- K852844 — AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
- K850936 — TOTAL PROTEINS
- K852006 — TP BIURET REAGENT
- K851877 — TOTAL PROTEIN LIQUID STABLE REAGENT SET
- K844331 — TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
- K843701 — TOTAL PROTEIN REAGENT SET
- K843028 — TOTAL PROTEIN ASSAY KIT
- K843107 — SYSTEMATE TOTAL PROTEIN 67218
- K841466 — TOTAL PROTEIN REAGENT BIURET
- K841069 — SERUM TOTAL PROTEIN REAGENT SET
- K845052 — PARAMAX TOTAL PROTEIN REAGENT TP
- K840290 — MCS TOTAL PROTEIN REAGENT
- K833950 — TOTAL PROTEIN REAGENT CS-724
- K832169 — TOTAL PROTEIN PROCEDURE
- K830538 — FLOW-PAC TOTAL PROTEIN REAGENT SET
- K823579 — COBAS REAGENT FOR TOTAL PROTEIN
- K823170 — LIQUIZYME TOTAL PROTEIN REAGENT
- K822468 — PSI TOTAL PROTEIN REAGENT
- K821905 — BIURET (COLORIMETRIC) TOTAL PROTEIN
- K821210 — SERUM TOTAL PROTEIN REAGENT SET
- K820913 — RA-1000 SYSTEM ADD'L ANALYTES PHASE III
- K813536 — ASTRA TOTAL PROTEIN REAGENT
- K812833 — TOTAL PROTEIN REAGENT SET
- K813038 — ULTRACHEM TP, ITEM #64974
- K812028 — KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
- K811673 — TOTAL PROTEIN TEST
- K802310 — IL TOTAL PROTEIN REAGENT
- K802161 — BIURET REAGENT & TOTAL PROTEIN BLANK SOL
- K801749 — BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
- K801061 — TOTAL PROTEIN TEST
- K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
Data sourced from openFDA. This site is unofficial and independent of the FDA.