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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 a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2019-05-23 under approval 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. It is manufactured by Hologic, Inc.. The 510(k) number is K190515.

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

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

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 QEP.

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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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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