Document Chem III Calibration Verification Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K923793 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K972904 Active Cleared 20 Feb 1998

• Document Enzyme Linearity Test Sets

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  FDA 510(k) K861506 Active Cleared 13 Jun 1986

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  FDA 510(k) K944338 Active Cleared 15 Nov 1994

• Document(Tm) Triglyceride Linearity Test Set

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  FDA 510(k) K893140 Active Cleared 23 Jun 1989

• Document Chem I Calibration Verification Test Set

  Class I

  FDA 510(k) K923795 Active Cleared 5 Nov 1992

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