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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2017-06-15 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K162673.

When did Aptima Herpes Simplex Viruses 1 & 2 Assay receive FDA 510(k) clearance?

Aptima Herpes Simplex Viruses 1 & 2 Assay received FDA 510(k) clearance on 2017-06-15, under 510(k) number K162673.

Who is the listed applicant for Aptima Herpes Simplex Viruses 1 & 2 Assay?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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