SIGMA BUN REAGENT— 510(k) K933679

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K933679 for SIGMA BUN REAGENT, Substantially Equivalent on 1993-12-17. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code LFP
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1993-07-28
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.