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FDA 510(k)

COBAS CT/NG V2.0 TEST

K-Number: K132270 · 2013-12-02

ApplicantRoche Molecular Systems, Inc.
Decision Date2013-12-02
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COBAS CT/NG V2.0 TEST is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2013-12-02 under 510(k) number K132270. 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 COBAS CT/NG V2.0 TEST?

COBAS CT/NG V2.0 TEST is a medical device that received FDA 510(k) clearance on 2013-12-02. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K132270.

When did COBAS CT/NG V2.0 TEST receive FDA 510(k) clearance?

COBAS CT/NG V2.0 TEST received FDA 510(k) clearance on 2013-12-02, under 510(k) number K132270.

Who is the listed applicant for COBAS CT/NG V2.0 TEST?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS CT/NG V2.0 TEST?

The FDA product code for COBAS CT/NG V2.0 TEST is LSL.

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Other records listing Roche Molecular Systems, Inc. as applicant

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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.K132251APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated

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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