CJW · Bromcresol Purple Dye-Binding, Albumin
Clinical Chemistry · 21 CFR 862.1035 · Class 2
Overview
| Product Code | CJW |
|---|---|
| Device Name | Bromcresol Purple Dye-Binding, Albumin |
| Regulation | 21 CFR 862.1035 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Classification Rationale
Class II.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | Mar 18, 2022 | SESE |
| K193001 | Albumin BCP | SENTINEL CH. SpA | Dec 19, 2019 | SESE |
| K132664 | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Oct 16, 2013 | SESE |
| K021636 | ALBUMIN REAGENT | Intersect Systems, Inc. | Jul 17, 2002 | SESE |
| K000483 | RANDOX ALBUMIN | Randox Laboratories, Ltd. | Mar 31, 2000 | SESE |
| K990978 | ALBUMIN BCG, MODEL AL 103-01 | A.P. Total Care, Inc. | May 25, 1999 | SESE |
| K981814 | ALBP | Abbott Laboratories | Jul 22, 1998 | SESE |
| K981457 | ALBP | Abbott Mfg., Inc. | May 27, 1998 | SESE |
| K913025 | ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 | Em Diagnostic Systems, Inc. | Oct 9, 1991 | SESE |
| K905776 | ALBUMIN REAGENT SET | Biochemical Trade, Inc. | Feb 26, 1991 | SESE |
| K863226 | ALBUMIN (BCP) | Sigma Diagnostics, Inc. | Sep 17, 1986 | SESE |
| K863004 | EMDS(TM) ALBUMIN TESTPACKS, #67652/95 | Em Diagnostic Systems, Inc. | Sep 16, 1986 | SESE |
| K862138 | VISION ALBUMIN | Abbott Laboratories | Jun 17, 1986 | SESE |
| K860423 | A-GENT LIQUID ALBUMIN | Abbott Laboratories | Mar 17, 1986 | SESE |
| K844426 | ALBUMIN BCP | Boehringer Mannheim Corp. | Jan 7, 1985 | SESE |
| K842847 | WAKO AUTOMATED REAGENTS FOR HITACHI 705 | Wako Chemicals USA, Inc. | Dec 11, 1984 | SESE |
| K832632 | ALBUMIN PROCEDURE BCP | Sandare Chemical Co., Inc. | Sep 12, 1983 | SESE |
| K830934 | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN | Quantimetrix Corp. | Apr 18, 1983 | SESE |
Top Applicants
- Abbott Laboratories — 3 clearances
- Em Diagnostic Systems, Inc. — 2 clearances
- A.P. Total Care, Inc. — 1 clearance
- Abbott Ireland Diagnostics Division — 1 clearance
- Abbott Mfg., Inc. — 1 clearance
