Albumin Procedure BCP
by Sandare Chemical Co., Inc. 510(k)
Active
510(k) K832632
Overview
Albumin Procedure BCP is a bromcresol purple dye-binding assay for albumin, classified under Clinical Chemistry. It is an in vitro diagnostic device used for the quantitative determination of albumin in serum or plasma samples.
The device is supplied as a reagent system for laboratory use, requiring appropriate storage conditions as specified by the manufacturer. It is a traditional 510(k) cleared product with product code CJW and regulation number 862.1035, intended for use in clinical chemistry laboratories.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832632 | Date12 Sep 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CJW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1035
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Sandare Chemical Co., Inc.
Questions
What is the ALBUMIN PROCEDURE BCP used for?
The ALBUMIN PROCEDURE BCP is an in vitro diagnostic device used for the quantitative determination of albumin in serum or plasma samples, employing a bromcresol purple dye-binding assay method within clinical chemistry testing.
How is the ALBUMIN PROCEDURE BCP supplied and stored?
The device is supplied as a reagent system for laboratory use and requires appropriate storage conditions as specified by the manufacturer to maintain stability and performance.
Is the ALBUMIN PROCEDURE BCP a single-use or reusable reagent system?
As a traditional 510(k) cleared reagent system for quantitative albumin testing, the ALBUMIN PROCEDURE BCP is intended for single-use per test run in clinical chemistry laboratories, consistent with standard reagent consumption for such assays.
What regulatory pathway was used for the ALBUMIN PROCEDURE BCP?
The ALBUMIN PROCEDURE BCP received clearance through the traditional 510(k) pathway, identified by k-number K832632, and is classified under product code CJW with regulation number 862.1035.