Aptima Herpes Simplex Viruses 1 & 2 Assay— 510(k) K162673

Name: FDA 510(k) clearance K162673
Creator: U.S. Food and Drug Administration
Published: 2017-06-15

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K162673 for Aptima Herpes Simplex Viruses 1 & 2 Assay, Substantially Equivalent on 2017-06-15. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code OQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2016-09-26
Decision date: 2017-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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