Aptima Herpes Simplex Viruses 1 & 2 Assay
K-Number: K162673 · 2017-06-15
ApplicantHologic, Inc.
Decision Date2017-06-15
Product CodeOQO
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Aptima Herpes Simplex Viruses 1 & 2 Assay is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2017-06-15 under approval number K162673. The device is classified under product code OQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aptima Herpes Simplex Viruses 1 & 2 Assay?
Aptima Herpes Simplex Viruses 1 & 2 Assay is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Hologic, Inc.. The 510(k) number is K162673.
When was Aptima Herpes Simplex Viruses 1 & 2 Assay approved by the FDA?
Aptima Herpes Simplex Viruses 1 & 2 Assay received FDA 510(k) clearance on 2017-06-15, under approval number K162673.
What company makes Aptima Herpes Simplex Viruses 1 & 2 Assay?
Aptima Herpes Simplex Viruses 1 & 2 Assay is manufactured by Hologic, Inc..
What is the FDA product code for Aptima Herpes Simplex Viruses 1 & 2 Assay?
The FDA product code for Aptima Herpes Simplex Viruses 1 & 2 Assay is OQO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.