STAPHAUREX ZL30— 510(k) K851949

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K851949 for STAPHAUREX ZL30, Substantially Equivalent on 1985-05-22. Applicant: Wellcome Diagnostics. Device class: 1.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code GTN
Device class: Class 1
Regulation: 21 CFR 866.3700
Advisory panel: Microbiology
Date received: 1985-05-03
Decision date: 1985-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

Download summary PDF View on FDA.gov ↗

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