CEK · Biuret (Colorimetric), Total Protein
Clinical Chemistry · 21 CFR 862.1635 · Class 2
Overview
| Product Code | CEK |
|---|---|
| Device Name | Biuret (Colorimetric), Total Protein |
| Regulation | 21 CFR 862.1635 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 116)
Showing 20 most recent of 116 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992846 | HICHEM TOTAL PROTEIN REAGENT | Elan Holdings, Inc. | Oct 18, 1999 | SESE |
| K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | Diagnostic Chemicals , Ltd. | Mar 2, 1998 | SESE |
| K980042 | CARESIDE TOTAL PROTEIN | Exigent Diagnostics, Inc. | Feb 4, 1998 | SESE |
| K971524 | TOTAL PROTEIN OR TP | Carolina Liquid Chemistries Corp. | May 16, 1997 | SESE |
| K961864 | CSF/URINE TOTAL PROTEIN | Teco Diagnostics | Oct 24, 1996 | SESE |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | Solarcare Technologies Corp,Inc. | May 30, 1996 | SESE |
| K955936 | TOTAL PROTEIN REAGENT | Derma Media Lab., Inc. | Mar 12, 1996 | SESE |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Dupont Medical Products | Aug 11, 1995 | SESE |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Emd Chemicals, Inc. | Jun 14, 1995 | SESE |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | Emd Chemicals, Inc. | May 15, 1995 | SESE |
| K943004 | TOTAL PROTEIN QVET | Prisma Systems | Dec 9, 1994 | SESE |
| K941496 | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY | Solarcare, Inc. | Oct 27, 1994 | SESE |
| K942424 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | Sep 6, 1994 | SESE |
| K934841 | URINARY/CEREBROSPINAL FLUID PROTEIN | E.I. Dupont DE Nemours & Co., Inc. | Apr 6, 1994 | SESE |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE |
| K921412 | MICROPROTEIN REAGENT SET | Sterling Diagnostics, Inc. | Jan 21, 1993 | SESE |
| K924659 | OLYUMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | Dec 29, 1992 | SESE |
| K922467 | SYNCHRON TOTAL PROTEIN TEST --MODIFIED | Beckman Instruments, Inc. | Nov 23, 1992 | SESE |
| K923267 | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | Sep 9, 1992 | SESE |
| K923266 | NOVA TOTAL PROTEIN MODULE | Nova Biomedical Corp. | Aug 12, 1992 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Harleco — 6 clearances
- Beckman Instruments, Inc. — 4 clearances
- Data Medical Associates, Inc. — 4 clearances
- Medical Analysis Systems, Inc. — 3 clearances
