BOUINS SOLUTION— 510(k) K833515

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K833515 for BOUINS SOLUTION, Substantially Equivalent on 1983-11-14. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code IGN
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1983-10-11
Decision date: 1983-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IGN

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K933679 — SIGMA BUN REAGENT1993-12-17
K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT1993-12-17

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