WELLCOGEN N. MENINGITIDIS A,C,Y W135— 510(k) K833063

Name: FDA 510(k) clearance K833063
Creator: U.S. Food and Drug Administration
Published: 1984-01-10

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K833063 for WELLCOGEN N. MENINGITIDIS A,C,Y W135, Substantially Equivalent on 1984-01-10. Applicant: Wellcome Diagnostics. Device class: 2.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code GTJ
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1983-09-09
Decision date: 1984-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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