WELLCOGEN BACTERIAL ANTIGEN KIT— 510(k) K854852

Name: FDA 510(k) clearance K854852
Creator: U.S. Food and Drug Administration
Published: 1986-02-04

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K854852 for WELLCOGEN BACTERIAL ANTIGEN KIT, Substantially Equivalent on 1986-02-04. 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: 1985-12-05
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

Download summary PDF View on FDA.gov ↗

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