Cholesterol Automated Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K761263 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ldh Isoenzyme Control Serum

  Class I

  FDA 510(k) K780096 Active Cleared 3 Mar 1978

• Uric Acid Std. for Quant. Uric Acid

  Class II

  FDA 510(k) K772025 Active Cleared 11 Nov 1977

• Inorganic Phosphorous Reagent

  Class I

  FDA 510(k) K760990 Active Cleared 16 Nov 1976

• Cholesterol Standards

  Class II

  FDA 510(k) K770277 Active Cleared 1 Mar 1977

• Inorganic Phosphorus Standards

  Class II

  FDA 510(k) K771143 Active Cleared 11 Jul 1977

• Statzyme Uric Acid Reagent

  Class I

  FDA 510(k) K770831 Active Cleared 11 Jul 1977

See all devices from Worthington Biochemical Corp. →