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FDA 510(k)

COBAS 4800 CT / NG TEST

K-Number: K110923 · 2012-01-24

ApplicantRoche Molecular Systems, Inc.
Decision Date2012-01-24
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COBAS 4800 CT / NG 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 2012-01-24 under 510(k) number K110923. The device is classified under product code MKZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS 4800 CT / NG TEST?

COBAS 4800 CT / NG TEST is a medical device that received FDA 510(k) clearance on 2012-01-24. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K110923.

When did COBAS 4800 CT / NG TEST receive FDA 510(k) clearance?

COBAS 4800 CT / NG TEST received FDA 510(k) clearance on 2012-01-24, under 510(k) number K110923.

Who is the listed applicant for COBAS 4800 CT / NG 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 4800 CT / NG TEST?

The FDA product code for COBAS 4800 CT / NG TEST is MKZ.

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Related Devices (Code: MKZ)

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.

K230451Aptima® Chlamydia trachomatis AssayHologic, Inc.K091724BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & COK090824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAYBecton, Dickinson & COK081824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & COK080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITAbbott Molecular, Inc.K070174AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORYRoche Diagnostics Corporation

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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