THE WELLCOME ROTAVIRUS LATEX TEST ZL40— 510(k) K861634

Name: FDA 510(k) clearance K861634
Creator: U.S. Food and Drug Administration
Published: 1986-10-29

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K861634 for THE WELLCOME ROTAVIRUS LATEX TEST ZL40, Substantially Equivalent on 1986-10-29. Applicant: Wellcome Diagnostics. Device class: 1.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1986-04-29
Decision date: 1986-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.