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FDA 510(k)

APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

K-Number: K132251 · 2013-10-17

ApplicantHologic / Gen-Probe Incorporated
Decision Date2013-10-17
Product CodeLSL
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 / Gen-Probe Incorporated. It received FDA 510(k) clearance on 2013-10-17 under 510(k) number K132251. 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 2013-10-17. The listed applicant is Hologic / Gen-Probe Incorporated. The 510(k) number is K132251.

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 2013-10-17, under 510(k) number K132251.

Who is the listed applicant for APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)?

The FDA 510(k) record lists Hologic / Gen-Probe Incorporated 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 LSL.

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Related Devices (Code: LSL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231329Aptima Neisseria gonorrhoeae AssayHologic, Inc.K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.K173840Xpert CT/NGCepheidK163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.K132270COBAS CT/NG V2.0 TESTRoche Molecular Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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