Sigma CO2 Alkaline Buffer Reagent

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K933691 ↗

FDA Product Code

JFL

Device Class

Class II

Regulation

21 CFR Part 862.1160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Dulbecco's Modified Eagle #D5523-

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• Ast Reagent (Procedure Number 158)

  Class II

  FDA 510(k) K892844 Active Cleared 20 Jun 1989

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  Class I

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