CPK1SOENZYMES Determination Pro. #715-Ep

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K761212 ↗

FDA Product Code

JHY

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alkaline Phosphatase, Leukocyte, Kit

  Class I

  FDA 510(k) K896092 Active Cleared 9 Nov 1989

• Apolipoprotein a-I (Apo a-I)

  Class I

  FDA 510(k) K901675 Active Cleared 26 Apr 1990

• Dulbecco's Modified Eagle's Med. (Dme) W/Glucose a

  Class I

  FDA 510(k) K850092 Active Cleared 27 Feb 1985

• Dulbecco's Modified Eagle #D5523-

  Class I

  FDA 510(k) K832688 Active Cleared 12 Sep 1983

• Ast Reagent (Procedure Number 158)

  Class II

  FDA 510(k) K892844 Active Cleared 20 Jun 1989

• (Mem) Eagle No. M3024 W/Earle's Salts

  Class I

  FDA 510(k) K873093 Active Cleared 25 Aug 1987

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