WI-38 GENCELLS— 510(k) K851561

Substantially Equivalent

Genus Diagnostics

FDA 510(k) clearance K851561 for WI-38 GENCELLS, Substantially Equivalent on 1985-05-10. Applicant: Genus Diagnostics.

Clearance details

Applicant: Genus Diagnostics
Product code: Code KIR
Advisory panel: Hematology
Date received: 1985-04-16
Decision date: 1985-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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