MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51— 510(k) K844762

Name: FDA 510(k) clearance K844762
Creator: U.S. Food and Drug Administration
Published: 1985-06-04

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K844762 for MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51, Substantially Equivalent on 1985-06-04. 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: 1984-12-07
Decision date: 1985-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

Download summary PDF View on FDA.gov ↗

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