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FDA 510(k)

ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST

K-Number: K964507 · 1997-06-13

ApplicantRoche Molecular Systems, Inc.
Decision Date1997-06-13
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS 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 1997-06-13 under 510(k) number K964507. 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 ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST?

ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K964507.

When did ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST receive FDA 510(k) clearance?

ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST received FDA 510(k) clearance on 1997-06-13, under 510(k) number K964507.

Who is the listed applicant for ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS 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 ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST?

The FDA product code for ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS 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.K110923COBAS 4800 CT / NG TESTRoche Molecular Systems, 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.

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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