FluChip-8G Influenza A+B Assay— 510(k) K182513

Substantially Equivalent

Indevr, Inc.

FDA 510(k) clearance K182513 for FluChip-8G Influenza A+B Assay, Substantially Equivalent on 2019-04-22. Applicant: Indevr, Inc..

Clearance details

Applicant: Indevr, Inc.
Product code: Code OZE
Advisory panel: Microbiology
Date received: 2018-09-12
Decision date: 2019-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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