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FDA 510(k)

APTIMA COMBO 2 ASSAY

K-Number: K111409 · 2012-05-03

ApplicantGen-Probe, Inc.
Decision Date2012-05-03
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

APTIMA COMBO 2 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K111409. 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?

APTIMA COMBO 2 ASSAY is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K111409.

When did APTIMA COMBO 2 ASSAY receive FDA 510(k) clearance?

APTIMA COMBO 2 ASSAY received FDA 510(k) clearance on 2012-05-03, under 510(k) number K111409.

Who is the listed applicant for APTIMA COMBO 2 ASSAY?

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

What is the FDA product code for APTIMA COMBO 2 ASSAY?

The FDA product code for APTIMA COMBO 2 ASSAY is LSL.

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Other records listing Gen-Probe, Inc. as applicant

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.

K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERK063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEMK061509TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196

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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

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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