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FDA 510(k)

AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

K-Number: K070172 · 2007-04-17

ApplicantRoche Diagnostics Corporation
Decision Date2007-04-17
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE 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 2007-04-17 under 510(k) number K070172. 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 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE?

AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is a medical device that received FDA 510(k) clearance on 2007-04-17. The listed applicant is Roche Diagnostics Corporation. The 510(k) number is K070172.

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

AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE received FDA 510(k) clearance on 2007-04-17, under 510(k) number K070172.

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

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 NEISSERIA GONORRHOEAE?

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

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Other records listing Roche Diagnostics Corporation 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.

K112528ELECSYS T4 CALCHECK 5K070174AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY

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

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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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