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FDA 510(k)

AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY

K-Number: K070174 · 2007-04-16

ApplicantRoche Diagnostics Corporation
Decision Date2007-04-16
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corporation. It received FDA 510(k) clearance on 2007-04-16 under 510(k) number K070174. 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 AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY?

AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY is a medical device that received FDA 510(k) clearance on 2007-04-16. The listed applicant is Roche Diagnostics Corporation. The 510(k) number is K070174.

When did AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY receive FDA 510(k) clearance?

AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY received FDA 510(k) clearance on 2007-04-16, under 510(k) number K070174.

Who is the listed applicant for AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY?

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

What is the FDA product code for AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY?

The FDA product code for AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY is MKZ.

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Other records listing Roche Diagnostics Corporation as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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