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FDA 510(k)

LEGIONELLA CULTURE CONFIRMATIN KIT

K-Number: K851271 · 1985-07-08

ApplicantGen-Probe, Inc.
Decision Date1985-07-08
Product CodeGRO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA CULTURE CONFIRMATIN KIT 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 1985-07-08 under 510(k) number K851271. The device is classified under product code GRO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGIONELLA CULTURE CONFIRMATIN KIT?

LEGIONELLA CULTURE CONFIRMATIN KIT is a medical device that received FDA 510(k) clearance on 1985-07-08. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K851271.

When did LEGIONELLA CULTURE CONFIRMATIN KIT receive FDA 510(k) clearance?

LEGIONELLA CULTURE CONFIRMATIN KIT received FDA 510(k) clearance on 1985-07-08, under 510(k) number K851271.

Who is the listed applicant for LEGIONELLA CULTURE CONFIRMATIN KIT?

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 LEGIONELLA CULTURE CONFIRMATIN KIT?

The FDA product code for LEGIONELLA CULTURE CONFIRMATIN KIT is GRO.

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Other records listing Gen-Probe, Inc. as applicant

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Related Devices (Code: GRO)

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.

K834067LEGIONELLA DIFFERENTIATION DISKRemel Co.K802423PHADEBACT HAEMOPHILUS TESTPharmacia, Inc.K800493BACTOGEN-H. INFLUENZAE TYPE BArmkel, LLC

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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