Product code CEK
- Device name
- Biuret (Colorimetric), Total Protein
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1635
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992846 | HICHEM TOTAL PROTEIN REAGENT | Elan Holdings, Inc. | 1999-10-18 |
| K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | Diagnostic Chemicals , Ltd. | 1998-03-02 |
| K980042 | CARESIDE TOTAL PROTEIN | Exigent Diagnostics, Inc. | 1998-02-04 |
| K971524 | TOTAL PROTEIN OR TP | Carolina Liquid Chemistries Corp. | 1997-05-16 |
| K961864 | CSF/URINE TOTAL PROTEIN | Teco Diagnostics | 1996-10-24 |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | Solarcare Technologies Corp,Inc. | 1996-05-30 |
| K955936 | TOTAL PROTEIN REAGENT | Derma Media Lab., Inc. | 1996-03-12 |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Dupont Medical Products | 1995-08-11 |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-06-14 |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-05-15 |
| K943004 | TOTAL PROTEIN QVET | Prisma Systems | 1994-12-09 |
| K941496 | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY | Solarcare, Inc. | 1994-10-27 |
| K942424 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1994-09-06 |
| K934841 | URINARY/CEREBROSPINAL FLUID PROTEIN | E.I. Dupont DE Nemours & Co., Inc. | 1994-04-06 |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Em Diagnostic Systems, Inc. | 1993-12-16 |
| K921412 | MICROPROTEIN REAGENT SET | Sterling Diagnostics, Inc. | 1993-01-21 |
| K924659 | OLYUMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | 1992-12-29 |
| K922467 | SYNCHRON TOTAL PROTEIN TEST --MODIFIED | Beckman Instruments, Inc. | 1992-11-23 |
| K923267 | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 |
| K923266 | NOVA TOTAL PROTEIN MODULE | Nova Biomedical Corp. | 1992-08-12 |
| K922361 | OLYMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | 1992-07-16 |
| K920531 | WAKO AUTOKIT MICRO TP | Wako Chemicals USA, Inc. | 1992-07-14 |
| K915380 | MICROPROTEIN-PR | Sigma Diagnostics, Inc. | 1992-02-18 |
| K914885 | BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST | Beckman Instruments, Inc. | 1992-01-30 |
| K913225 | URINE/CSF MICROPROTEIN REAGENT | Intersect Systems, Inc. | 1991-10-11 |
| K913978 | TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE | Beckman Instruments, Inc. | 1991-10-09 |
| K912810 | ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 | Em Diagnostic Systems, Inc. | 1991-07-30 |
| K905790 | TOTAL PROTEIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-21 |
| K905661 | SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 | Em Diagnostic Systems, Inc. | 1991-01-31 |
| K904603 | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM | Quantitative Medicine, Inc. | 1991-01-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414654010 | Atellica CH Total Protein_2 | Siemens Healthcare Diagnostics Inc. | 2026-03-18 |
| 00850053916144 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-12 |
| 00630414306025 | Atellica CH Total Protein_2 | Siemens Healthcare Diagnostics Inc. | 2023-12-13 |
| 00630414611082 | Atellica CH Total Protein_2 | Siemens Healthcare Diagnostics Inc. | 2023-12-13 |
| 10673486002201 | Teco Diagnostics Total Protein Reagent Set | TECO DIAGNOSTICS | 2023-11-14 |
| 10673486002171 | Teco Diagnostics CSF/Urine Protein Reagent Set | TECO DIAGNOSTICS | 2023-11-14 |
| 10673486002218 | Teco Diagnostics Total Protein Reagent Kit for TC-Matrix | TECO DIAGNOSTICS | 2023-11-14 |
| 06971674862253 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862215 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862222 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862239 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862246 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862260 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862277 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862284 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862291 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 00630414279206 | Atellica CH UCFP | Siemens Healthcare Diagnostics Inc. | 2020-03-09 |
| 00630414279176 | ADVIA Chemistry UCFP | Siemens Healthcare Diagnostics Inc. | 2020-03-06 |
| 00896863002349 | QuanTtest Red Pyrogallol Red Reagent | QUANTIMETRIX CORPORATION | 2019-09-27 |
| M0513410021 | QuanTtest Human Protein Standards Set | QUANTIMETRIX CORPORATION | 2017-12-31 |
| M0512210021 | QuanTtest Red Reagent Total Protein Assay System | QUANTIMETRIX CORPORATION | 2017-06-30 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000281 | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000261 | Piccolo Hepatic Function Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000031 | Piccolo Liver Panel Plus | ABAXIS, INC. | 2016-09-23 |
| 04015630922833 | Total Protein Gen2 monocromatic | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630912445 | Total Protein | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630912438 | Total Protein | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630911875 | Total Protein | Roche Diagnostics GmbH | 2016-09-20 |