ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST— 510(k) K896859

Name: FDA 510(k) clearance K896859
Creator: U.S. Food and Drug Administration
Published: 1990-02-01

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K896859 for ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST, Substantially Equivalent on 1990-02-01. Applicant: Gen-Probe, Inc.. Device class: 2.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code MBT
Device class: Class 2
Regulation: 21 CFR 866.3320
Advisory panel: Microbiology
Date received: 1989-12-05
Decision date: 1990-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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