Flow-Pac Albumin Reagent

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K830536 ↗

FDA Product Code

CIX

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Flow-Pac Triglyceride Reagent

  Not classified

  FDA 510(k) K830957 Active Cleared 18 Apr 1983

• Bicarbonate Reagents Amresco Product #4326020

  Class II

  FDA 510(k) K904007 Active Cleared 13 Sep 1990

• Liquilyme Bun Reagent

  Class II

  FDA 510(k) K812945 Active Cleared 6 Nov 1981

• Amresco Subst Concen, Pro #2432, Buf, Nad, 2455, Tri

  Class II

  FDA 510(k) K852948 Active Cleared 7 Aug 1985

• Creatinine Reagent Set

  Class II

  FDA 510(k) K832439 Active Cleared 17 Jan 1984

• Amresco Flow Pac Chloride Reagent No. 2256 & 2271

  Class II

  FDA 510(k) K860662 Active Cleared 14 Mar 1986

See all devices from Amresco, Inc. →

• What is the Flow-Pac Albumin Reagent used for?

  The Flow-Pac Albumin Reagent is designed for clinical chemistry assays to measure serum albumin levels. It works by binding bromcresol green dye, enabling a quantitative colorimetric determination of albumin concentration in patient samples. This helps clinicians assess protein levels, which are critical for diagnosing and monitoring conditions like liver disease, malnutrition, or kidney disorders.

• How is the Flow-Pac Albumin Reagent supplied?

  This reagent is supplied as a single-use, non-sterile liquid. It is intended exclusively for in vitro diagnostic use in clinical laboratories. The specific lot sizes and storage instructions are typically detailed in the manufacturer’s accompanying documentation, though those specifics are not provided in the regulatory data.

• Is the Flow-Pac Albumin Reagent sterile?

  No, the Flow-Pac Albumin Reagent is explicitly labeled as non-sterile. Since it is intended for use in clinical laboratories, proper aseptic techniques should be followed when handling the reagent to prevent contamination of patient samples.

• What regulatory pathway does the Flow-Pac Albumin Reagent follow?

  The Flow-Pac Albumin Reagent is regulated under the FDA 510(k) clearance pathway, specifically under the Substantially Equivalent (SESE) decision category. It was cleared under product code CIX (Clinical Chemistry) and adheres to FDA regulation 862.1035. The clearance number is K860661, though the original submission was filed under K830536 in 1983.

• Are there different models or sizes available for the Flow-Pac Albumin Reagent?

  The regulatory data lists multiple FEI numbers (e.g., 3004192065, 3006716639), which may correspond to different lot or batch identifiers rather than distinct models or sizes. For precise details on available lot sizes or variations, refer to the manufacturer’s documentation or contact Amresco, Inc. directly.