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FDA 510(k)

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091

K-Number: K062440 · 2006-11-07

ApplicantGen-Probe, Inc.
Decision Date2006-11-07
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 2006-11-07 under 510(k) number K062440. 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 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091?

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 is a medical device that received FDA 510(k) clearance on 2006-11-07. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K062440.

When did GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 receive FDA 510(k) clearance?

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 received FDA 510(k) clearance on 2006-11-07, under 510(k) number K062440.

Who is the listed applicant for GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091?

The FDA 510(k) record lists Gen-Probe, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091?

The FDA product code for GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 is LSL.

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Other records listing Gen-Probe, Inc. as applicant

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Related Devices (Code: LSL)

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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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