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FDA 510(k)

GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM

K-Number: K860498 · 1986-07-16

ApplicantGen-Probe, Inc.
Decision Date1986-07-16
Product CodeLQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM 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 1986-07-16 under 510(k) number K860498. The device is classified under product code LQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM?

GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K860498.

When did GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1986-07-16, under 510(k) number K860498.

Who is the listed applicant for GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM?

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 LEGIONELLA RAPID DIAGNOSTIC SYSTEM?

The FDA product code for GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM is LQH.

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Other records listing Gen-Probe, Inc. as applicant

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Related Devices (Code: LQH)

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.

K033861BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAYBecton, Dickinson & CO

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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