Amylase for Manual/Automated Applications

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K902326 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase (Alt)/(Gpt)

  Class I

  FDA 510(k) K870086 Active Cleared 6 Mar 1987

• Aspartate Aminotransferase (Ast)/(Got)

  Class II

  FDA 510(k) K870077 Active Cleared 6 Mar 1987

• Uibc for Discreet Random Access Analyzer

  Class I

  FDA 510(k) K932871 Active Cleared 8 Sep 1993

• Direct Bilirubin for Manual or Automated Appli.

  Class II

  FDA 510(k) K892905 Active Cleared 19 Jun 1989

• Magnesium

  Class I

  FDA 510(k) K903341 Active Cleared 22 Aug 1990

• Uric Acid for Manual/Automated Applications

  Class I

  FDA 510(k) K895821 Active Cleared 5 Dec 1989

See all devices from Catachem, Inc. →

• What is Amylase for Manual/Automated Applications used for?

  It is an in vitro diagnostic reagent used for the quantitative determination of amylase in serum, intended for use in clinical chemistry testing in laboratory settings.

• How is Amylase for Manual/Automated Applications supplied?

  The device is supplied as a reagent for clinical chemistry testing and is designed for use in manual or automated laboratory applications.

• Is Amylase for Manual/Automated Applications sterile or single-use?

  No information regarding sterility, single-use or reusable status is provided in the device data, so these details cannot be confirmed from the available information.

• What sizes or models are available for Amylase for Manual/Automated Applications?

  No information regarding sizes, models, or reference numbers is provided in the device data, so specific sizing or model details cannot be determined from the available information.

• What are the storage conditions for Amylase for Manual/Automated Applications?

  No information regarding storage conditions is provided in the device data, so specific storage requirements cannot be confirmed from the available details.