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FDA 510(k)

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

K-Number: K053289 · 2006-08-10

ApplicantRoche Diagnostics Corp.
Decision Date2006-08-10
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2006-08-10 under 510(k) number K053289. 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 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE?

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is a medical device that received FDA 510(k) clearance on 2006-08-10. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K053289.

When did COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE receive FDA 510(k) clearance?

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE received FDA 510(k) clearance on 2006-08-10, under 510(k) number K053289.

Who is the listed applicant for COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE?

The FDA product code for COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is LSL.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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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