Gdh-Glucose (Rate) Reagent Kit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K770062 ↗

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K934045 Active Cleared 14 Oct 1993

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  Class II

  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

  Class I

  FDA 510(k) K821812 Active Cleared 2 Jul 1982

• Immage Immunochemistry System Alpha-2-Macroglobulin Reagent

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  FDA 510(k) K974564 Active Cleared 17 Feb 1998

• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

  Class II

  FDA 510(k) K964762 Active Cleared 25 Apr 1997

• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

  Class II

  FDA 510(k) K963286 Active Cleared 7 Oct 1996

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