Gemsaec Appli. for Ultrazyme Plus Y-Amyl

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K772035 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ultra Zyme Plus Ck-1 #64978, 65027 & 28

  Class II

  FDA 510(k) K812593 Active Cleared 2 Oct 1981

• Ultrachem Phosphorus, 64973

  Class I

  FDA 510(k) K772156 Active Cleared 6 Dec 1977

• Ultrachem Total Protein, #64974

  Class II

  FDA 510(k) K772155 Active Cleared 6 Dec 1977

• Ultrazyme Plus Alp

  Class II

  FDA 510(k) K770870 Active Cleared 14 Jul 1977

• Ultra Zyme Plus Gpt, #64956, 65035 & 36

  Class I

  FDA 510(k) K812591 Active Cleared 24 Sep 1981

• Ultrazyme Alkaline Phosphatase

  Class II

  FDA 510(k) K760024 Active Cleared 26 Aug 1976

See all devices from Harleco →

• What is the GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL used for?

  The GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL is designed for catalytic methods in clinical chemistry specifically for amylase testing. It works with the Ultrazyme Plus system to measure amylase levels in patient samples in clinical laboratory settings.

• How is the GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL supplied?

  The device is supplied by Harleco as part of their line of clinical chemistry products. It is intended for use in clinical laboratory settings and is designed to work specifically with the Ultrazyme Plus system for amylase testing.

• What is the regulatory status of the GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL?

  The device is authorized under FDA 510(k) clearance with number K772035. It is classified as a Class II device regulated under 862.1070 and was determined to be substantially equivalent through a traditional clearance process.

• Is the GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL reusable or single-use?

  The device information does not specify whether it is designed for single-use or reuse. The description indicates it is part of a system for amylase testing in clinical chemistry, but specific details about usage limitations are not provided in the device data.