FDA Product Code
FDA Product Code CEK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1635
510(k) Clearances — 116 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K992846 | HICHEM TOTAL PROTEIN REAGENT | Elan Holdings, Inc. | 1999-10-18 | Traditional | PDF ↗ |
| K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | Diagnostic Chemicals , Ltd. | 1998-03-02 | Traditional | PDF ↗ |
| K980042 | CARESIDE TOTAL PROTEIN | Exigent Diagnostics, Inc. | 1998-02-04 | Traditional | PDF ↗ |
| K971524 | TOTAL PROTEIN OR TP | Carolina Liquid Chemistries Corp. | 1997-05-16 | Traditional | PDF ↗ |
| K961864 | CSF/URINE TOTAL PROTEIN | Teco Diagnostics | 1996-10-24 | Traditional | PDF ↗ |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | Solarcare Technologies Corp,Inc. | 1996-05-30 | Traditional | PDF ↗ |
| K955936 | TOTAL PROTEIN REAGENT | Derma Media Lab., Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Dupont Medical Products | 1995-08-11 | Traditional | PDF ↗ |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K943004 | TOTAL PROTEIN QVET | Prisma Systems | 1994-12-09 | Traditional | PDF ↗ |
| K941496 | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY | Solarcare, Inc. | 1994-10-27 | Traditional | PDF ↗ |
| K942424 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1994-09-06 | Traditional | PDF ↗ |
| K934841 | URINARY/CEREBROSPINAL FLUID PROTEIN | E.I. Dupont DE Nemours & Co., Inc. | 1994-04-06 | Traditional | PDF ↗ |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Em Diagnostic Systems, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K921412 | MICROPROTEIN REAGENT SET | Sterling Diagnostics, Inc. | 1993-01-21 | Traditional | PDF ↗ |
| K924659 | OLYUMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | 1992-12-29 | Traditional | PDF ↗ |
| K922467 | SYNCHRON TOTAL PROTEIN TEST --MODIFIED | Beckman Instruments, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K923267 | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K923266 | NOVA TOTAL PROTEIN MODULE | Nova Biomedical Corp. | 1992-08-12 | Traditional | PDF ↗ |
| K922361 | OLYMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | 1992-07-16 | Traditional | PDF ↗ |
| K920531 | WAKO AUTOKIT MICRO TP | Wako Chemicals USA, Inc. | 1992-07-14 | Traditional | PDF ↗ |
| K915380 | MICROPROTEIN-PR | Sigma Diagnostics, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K914885 | BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST | Beckman Instruments, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K913225 | URINE/CSF MICROPROTEIN REAGENT | Intersect Systems, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K913978 | TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE | Beckman Instruments, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K912810 | ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 | Em Diagnostic Systems, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K905790 | TOTAL PROTEIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K905661 | SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 | Em Diagnostic Systems, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K904603 | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM | Quantitative Medicine, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K903511 | SYNERMED TOTAL PROTEIN REAGENT KIT | Synermed, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K901527 | BIURET (COLORMETRIC), TOTAL PROTEIN | American Research Products Co. | 1990-07-19 | Traditional | PDF ↗ |
| K900733 | PROTEIN TEST FOR URINE AND CSF | Elite Technology, Inc. | 1990-07-10 | Traditional | PDF ↗ |
| K897166 | COULTER TOTAL PROTEIN REAGENT | Coulter Electronics, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K896230 | COBAS READY TOTAL PROTEIN REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896916 | CLINISTAT TOTAL PROTEIN REAGENT TEST | Heraeus Kulzer, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K893915 | EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 | Em Diagnostic Systems, Inc. | 1989-08-31 | Traditional | PDF ↗ |
| K890618 | COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT | Kenlor Industries, Inc. | 1989-05-22 | Traditional | PDF ↗ |
| K890868 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1989-03-20 | Traditional | PDF ↗ |
| K890278 | TOTAL PROTEIN REAGENT | Sigma Chemical Co. | 1989-03-09 | Traditional | PDF ↗ |
| K890317 | TOTAL PROTEIN REAGENT | Medical Analysis Systems, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K884703 | TOTAL PROTEIN TEST (TP) ITEM #65670 | Em Diagnostic Systems, Inc. | 1989-01-23 | Traditional | PDF ↗ |
| K884225 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS | A-Kem, Inc. | 1988-12-09 | Traditional | PDF ↗ |
| K881639 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) | Eastman Kodak Company | 1988-07-08 | Traditional | PDF ↗ |
| K882189 | BIOTROL TOTAL PROTEIN H.P. | Biotrol, USA, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K880312 | WAKO(TM) AUTOKIT TOTAL PROTEIN | Wako Chemicals USA, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K880677 | TOTAL PROTEIN REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K875222 | TOTAL PROTEIN | Catachem, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K874476 | EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 | Em Diagnostic Systems, Inc. | 1987-11-25 | Traditional | PDF ↗ |
| K870371 | TOTAL PROTEIN REAGENT - BIURET METHOD | Trace Scientific , Ltd. | 1987-08-19 | Traditional | PDF ↗ |
| K871975 | MULTICHEM TOTAL PROTEIN REAGENT #S0928 | Simmler, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K864743 | BIURET (COLORIMETRIC), TOTAL PROTEIN | Tech-Co, Inc. | 1987-01-13 | Traditional | PDF ↗ |
| K863258 | TOTAL PROTEIN PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K863301 | DEMAND TOTAL PROTEIN | Cooper Biomedical, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863074 | TOTAL PROTEINS | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K863005 | EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 | Em Diagnostic Systems, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K861508 | WAKO MICRO TP | Wako Chemicals USA, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K861798 | VISION TOTAL PROTEIN | Abbott Laboratories | 1986-06-17 | Traditional | PDF ↗ |
| K861663 | TOTAL PROTEIN PROCEDURE | Data Medical Associates, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K860917 | EASY-TEST TOTAL PROTEIN (TP), #67513/93 | Em Diagnostic Systems, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K860426 | A-GENT LIQUID TOTAL PROTEIN | Abbott Laboratories | 1986-04-03 | Traditional | PDF ↗ |
| K860341 | TOTAL PROTEIN (BIURET) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K854717 | NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 | Nobel Scientific Industries, Inc. | 1986-01-14 | Traditional | PDF ↗ |
| K855191 | TOTAL PROTEIN REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K853932 | QUANTTEST TOTAL PROTEIN ASSAY | Quantimetrix Corp. | 1985-12-19 | Traditional | PDF ↗ |
| K853930 | QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT | Quantimetrix Corp. | 1985-12-10 | Traditional | PDF ↗ |
| K854553 | TOTAL PROTEIN | American Monitor Corp. | 1985-11-25 | Traditional | PDF ↗ |
| K853681 | SIGMA 610 FOR PROTEIN IN URINE & CSF | Sigma Diagnostics, Inc. | 1985-10-28 | Traditional | PDF ↗ |
| K853244 | TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE | Simmler, Inc. | 1985-08-12 | Traditional | PDF ↗ |
| K852844 | AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC | American Research Products Co. | 1985-07-22 | Traditional | PDF ↗ |
| K850936 | TOTAL PROTEINS | Dilab, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K852006 | TP BIURET REAGENT | Alpkem Corp. | 1985-06-10 | Traditional | PDF ↗ |
| K851877 | TOTAL PROTEIN LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K844331 | TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K843701 | TOTAL PROTEIN REAGENT SET | Livonia Diagnostics, Inc. | 1984-10-01 | Traditional | PDF ↗ |
| K843107 | SYSTEMATE TOTAL PROTEIN 67218 | Em Diagnostic Systems, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K843028 | TOTAL PROTEIN ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-27 | Traditional | PDF ↗ |
| K841466 | TOTAL PROTEIN REAGENT BIURET | Reagents Applications, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K841069 | SERUM TOTAL PROTEIN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K845052 | PARAMAX TOTAL PROTEIN REAGENT TP | American Dade | 1984-04-13 | Traditional | PDF ↗ |
| K840290 | MCS TOTAL PROTEIN REAGENT | Medilab Corp. | 1984-03-30 | Traditional | PDF ↗ |
| K833950 | TOTAL PROTEIN REAGENT CS-724 | Fisher Scientific Co., LLC | 1984-01-13 | Traditional | PDF ↗ |
| K832169 | TOTAL PROTEIN PROCEDURE | Sandare Chemical Co., Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K830538 | FLOW-PAC TOTAL PROTEIN REAGENT SET | Amresco, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | Hoffmann-La Roche, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K823170 | LIQUIZYME TOTAL PROTEIN REAGENT | Amresco, Inc. | 1982-11-29 | Traditional | PDF ↗ |
| K822468 | PSI TOTAL PROTEIN REAGENT | Pointe Scientific, Inc., | 1982-09-14 | Traditional | PDF ↗ |
| K821905 | BIURET (COLORIMETRIC) TOTAL PROTEIN | American Monitor Corp. | 1982-07-20 | Traditional | PDF ↗ |
| K821210 | SERUM TOTAL PROTEIN REAGENT SET | Omega Medical Electronics | 1982-07-13 | Traditional | PDF ↗ |
| K820913 | RA-1000 SYSTEM ADD'L ANALYTES PHASE III | Technicon Instruments Corp. | 1982-05-03 | Traditional | PDF ↗ |
| K813536 | ASTRA TOTAL PROTEIN REAGENT | Hi Chem, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K812833 | TOTAL PROTEIN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-11-27 | Traditional | PDF ↗ |
| K813038 | ULTRACHEM TP, ITEM #64974 | Harleco | 1981-11-10 | Traditional | PDF ↗ |
| K812028 | KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) | Eastman Kodak Company | 1981-08-03 | Traditional | PDF ↗ |
| K811673 | TOTAL PROTEIN TEST | King Diagnostics, Inc. | 1981-06-25 | Traditional | PDF ↗ |
| K802310 | IL TOTAL PROTEIN REAGENT | Instrumentation Laboratory CO | 1980-10-23 | Traditional | PDF ↗ |
| K802161 | BIURET REAGENT & TOTAL PROTEIN BLANK SOL | Panmed, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K801749 | BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM | Beckman Instruments, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801061 | TOTAL PROTEIN TEST | Environmental Chemical Specialties | 1980-07-21 | Traditional | PDF ↗ |
| K800674 | SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
Product code CEK · Class II · Clinical Chemistry. Data: openFDA.