HISTOPAQUE-1077— 510(k) K842146

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K842146 for HISTOPAQUE-1077, Substantially Equivalent on 1984-07-27. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code JCF
Device class: Class 1
Regulation: 21 CFR 864.8500
Advisory panel: Hematology
Date received: 1984-05-30
Decision date: 1984-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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