RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX— 510(k) K862614

Name: FDA 510(k) clearance K862614
Creator: U.S. Food and Drug Administration
Published: 1986-11-10

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K862614 for RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX, Substantially Equivalent on 1986-11-10. 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: 1986-07-09
Decision date: 1986-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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