Wako Phospholipids Test

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K801076 ↗

FDA Product Code

CEL

Device Class

Class I

Regulation

21 CFR Part 862.1575

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ammonia Test

  Class I

  FDA 510(k) K813366 Active Cleared 22 Dec 1981

• Wako Triglyceride-G Test

  Class I

  FDA 510(k) K801891 Active Cleared 16 Sep 1980

• Wako Triglyceride

  Class I

  FDA 510(k) K791597 Active Cleared 17 Sep 1979

• Wako Hdl Cholesterol Test

  Class I

  FDA 510(k) K801834 Active Cleared 16 Sep 1980

• Wako Glucose C

  Class II

  FDA 510(k) K842221 Active Cleared 12 Jul 1984