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FDA 510(k)

Aptima Combo 2 Assay (Panther System)

K-Number: K180681 · 2018-06-13

ApplicantHologic, Inc.
Decision Date2018-06-13
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Aptima Combo 2 Assay (Panther System) is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K180681. The device is classified under product code LSL. 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 2018-06-13. It is manufactured by Hologic, Inc.. The 510(k) number is K180681.

When was Aptima Combo 2 Assay (Panther System) approved by the FDA?

Aptima Combo 2 Assay (Panther System) received FDA 510(k) clearance on 2018-06-13, under approval number K180681.

What company makes Aptima Combo 2 Assay (Panther System)?

Aptima Combo 2 Assay (Panther System) is manufactured by Hologic, Inc..

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 LSL.

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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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