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FDA 510(k)

Aptima Combo 2 Assay (Panther System)

K-Number: K190515 · 2019-05-23

ApplicantHologic, Inc.
Decision Date2019-05-23
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima Combo 2 Assay (Panther System) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K190515. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptima Combo 2 Assay (Panther System)?

Aptima Combo 2 Assay (Panther System) is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Hologic, Inc.. The 510(k) number is K190515.

When did Aptima Combo 2 Assay (Panther System) receive FDA 510(k) clearance?

Aptima Combo 2 Assay (Panther System) received FDA 510(k) clearance on 2019-05-23, under 510(k) number K190515.

Who is the listed applicant for Aptima Combo 2 Assay (Panther System)?

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 Combo 2 Assay (Panther System)?

The FDA product code for Aptima Combo 2 Assay (Panther System) is QEP.

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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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