GAS GENERATING KIT SYSTEM FOR CAMPYLOB.— 510(k) K802494

Name: FDA 510(k) clearance K802494
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K802494 for GAS GENERATING KIT SYSTEM FOR CAMPYLOB., Substantially Equivalent on 1980-11-12. Applicant: Oxoid U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code KZJ
Device class: Class 1
Regulation: 21 CFR 866.2580
Advisory panel: Microbiology
Date received: 1980-10-10
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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