Astra Systems Amylase Chemistry

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

Full name

Bekcman Astra Systems Amylase Chemistry

510(k) Number

K802581 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Beckman Hdl Cholesterol Reagent

  Class I

  FDA 510(k) K934045 Active Cleared 14 Oct 1993

• Beckman Urine Protein Calibrator (Ucal)

  Class II

  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

  Class I

  FDA 510(k) K821812 Active Cleared 2 Jul 1982

• Immage Immunochemistry System Alpha-2-Macroglobulin Reagent

  Class II

  FDA 510(k) K974564 Active Cleared 17 Feb 1998

• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

  Class II

  FDA 510(k) K964762 Active Cleared 25 Apr 1997

• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

  Class II

  FDA 510(k) K963286 Active Cleared 7 Oct 1996

See all devices from Beckman Instruments, Inc. →

• What is the Astra Systems Amylase Chemistry used for?

  This device is a catalytic method intended for diagnostic testing to assess amylase activity levels in biological samples.

• Is the reagent kit sterile or reusable?

  The device is supplied as a reagent kit and is intended for single-use applications. It is not specified as sterile or reusable.

• How is the product regulated?

  The Astra Systems Amylase Chemistry is regulated under FDA 510(k) clearance.

• What are the storage requirements for the reagent kit?

  Storage requirements and specific sizes are not provided in the device data.