BIOTIS BIGGY AGAR & BIGGY SLANT— 510(k) K843761

Name: FDA 510(k) clearance K843761
Creator: U.S. Food and Drug Administration
Published: 1984-10-10

Substantially Equivalent

Otisville Biotech, Inc.

FDA 510(k) clearance K843761 for BIOTIS BIGGY AGAR & BIGGY SLANT, Substantially Equivalent on 1984-10-10. Applicant: Otisville Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Otisville Biotech, Inc.
Product code: Code JSI
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1984-09-25
Decision date: 1984-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otisville, NY, US

Download summary PDF View on FDA.gov ↗

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