SIMPLEX-2— 510(k) K832541

Substantially Equivalent

Gentech Australia

FDA 510(k) clearance K832541 for SIMPLEX-2, Substantially Equivalent on 1984-02-04. Applicant: Gentech Australia.

Clearance details

Applicant: Gentech Australia
Product code: Code GQN
Advisory panel: Microbiology
Date received: 1983-07-29
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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