Chemistry Control, Abnormal

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770312 ↗

FDA Product Code

JJY

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Reagent Cpk, Enzyme

  Class II

  FDA 510(k) K770319 Active Cleared 5 Apr 1977

• Cholesterol Procedure, Tekpoint Total

  Class I

  FDA 510(k) K770457 Active Cleared 3 May 1977

• Glucose Procedure, Tekpoint Direct

  Class II

  FDA 510(k) K770455 Active Cleared 3 May 1977

• Reagent Got, Enzyme

  Class II

  FDA 510(k) K770318 Active Cleared 5 Apr 1977

• Ican K Dissector Sponges

  Class I

  FDA 510(k) K914083 Active Cleared 9 Oct 1991

• Chemistry Control, Normal

  Class I

  FDA 510(k) K770310 Active Cleared 5 Apr 1977

See all devices from Icn Pharmaceuticals, Inc. →