LEGIONELLA CULTURE CONFIRMATIN KIT— 510(k) K851271

Name: FDA 510(k) clearance K851271
Creator: U.S. Food and Drug Administration
Published: 1985-07-08

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K851271 for LEGIONELLA CULTURE CONFIRMATIN KIT, Substantially Equivalent on 1985-07-08. Applicant: Gen-Probe, Inc.. Device class: 2.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code GRO
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 1985-04-01
Decision date: 1985-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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