ISOAMP HSV ASSAY— 510(k) K111951

Substantially Equivalent

Biohelix Corporation

FDA 510(k) clearance K111951 for ISOAMP HSV ASSAY, Substantially Equivalent on 2011-09-27. Applicant: Biohelix Corporation. Device class: 2.

Clearance details

Applicant: Biohelix Corporation
Product code: Code OQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2011-07-08
Decision date: 2011-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, 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.