IDI-VANR ASSAY— 510(k) K061686

Substantially Equivalent

Geneohm Sciences Canada, Inc.

FDA 510(k) clearance K061686 for IDI-VANR ASSAY, Substantially Equivalent on 2006-08-30. Applicant: Geneohm Sciences Canada, Inc.. Device class: 2.

Clearance details

Applicant: Geneohm Sciences Canada, Inc.
Product code: Code NIJ
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2006-06-15
Decision date: 2006-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin, MD, US

Download summary PDF View on FDA.gov ↗

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