WELLCOLEX COLOUR SHIGELLA TEST ZC51— 510(k) K895461

Name: FDA 510(k) clearance K895461
Creator: U.S. Food and Drug Administration
Published: 1990-01-11

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K895461 for WELLCOLEX COLOUR SHIGELLA TEST ZC51, Substantially Equivalent on 1990-01-11. Applicant: Wellcome Diagnostics. Device class: 2.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code GNB
Device class: Class 2
Regulation: 21 CFR 866.3660
Advisory panel: Microbiology
Date received: 1989-09-06
Decision date: 1990-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

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