Apo-Screen Calibrator & Control Set for Hdl Apo A1

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K854875 ↗

FDA Product Code

DER

Device Class

Class II

Regulation

21 CFR Part 866.5580

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Apo-Screen Test Set for Hdl-Apolipoptein A-1

  Class II

  FDA 510(k) K853048 Active Cleared 28 Aug 1985

• Quikread Chem. Analyzer & Choles. for Serum/Plasma

  Class I

  FDA 510(k) K890267 Active Cleared 26 Apr 1989

• D-Chem

  Class I

  FDA 510(k) K882307 Active Cleared 2 Aug 1988

• Quikread Chem. Analyzer & Choles. for Whole Blood

  Class I

  FDA 510(k) K890027 Active Cleared 26 Apr 1989

• Quikread(R) Whole Blood Triglyceride Test Kit

  Class I

  FDA 510(k) K897169 Active Cleared 23 Feb 1990

• Apo a-I Immunoassay Test Set for Apolipoprotein A1

  Class II

  FDA 510(k) K851649 Active Cleared 5 Jun 1985

See all devices from Photec Diagnostics, Inc. →