BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH— 510(k) K850144

Name: FDA 510(k) clearance K850144
Creator: U.S. Food and Drug Administration
Published: 1985-06-17

Substantially Equivalent

American Sterilizer Co.

FDA 510(k) clearance K850144 for BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH, Substantially Equivalent on 1985-06-17. Applicant: American Sterilizer Co.. Device class: 2.

Clearance details

Applicant: American Sterilizer Co.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1985-01-14
Decision date: 1985-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erie, PA, US

Download summary PDF View on FDA.gov ↗

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