Checkpoint

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K931947 ↗

FDA Product Code

JPK

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Sgpt Reagent Set

  Class I

  FDA 510(k) K841060 Active Cleared 1 May 1984

• Alkaline Phosphotase Reagent Set

  Class II

  FDA 510(k) K841064 Active Cleared 1 May 1984

• Creatinine Reagent Set

  Class II

  FDA 510(k) K841070 Active Cleared 1 May 1984

• Glucose Enzymatic Reagent Set

  Class II

  FDA 510(k) K841055 Active Cleared 1 May 1984

• Msi-Cal 8

  Class II

  FDA 510(k) K883851 Active Cleared 22 Nov 1988

• Msi-Hct

  Class II

  FDA 510(k) K924926 Active Cleared 7 Jan 1993

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