RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE— 510(k) K890089

Name: FDA 510(k) clearance K890089
Creator: U.S. Food and Drug Administration
Published: 1989-03-13

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K890089 for RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE, Substantially Equivalent on 1989-03-13. Applicant: Gen-Probe, Inc.. Device class: 1.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code LQF
Device class: Class 1
Regulation: 21 CFR 866.3370
Advisory panel: Microbiology
Date received: 1989-01-10
Decision date: 1989-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.