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FDA 510(k)

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

K-Number: K974503 · 1999-12-01

ApplicantRoche Molecular Systems, Inc.
Decision Date1999-12-01
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE 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 1999-12-01 under 510(k) number K974503. 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 ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE?

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is a medical device that received FDA 510(k) clearance on 1999-12-01. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K974503.

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

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE received FDA 510(k) clearance on 1999-12-01, under 510(k) number K974503.

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

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 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE?

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

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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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