RAPID IDENTIFI-METHOD NEISSERIA KIT— 510(k) K830968

Name: FDA 510(k) clearance K830968
Creator: U.S. Food and Drug Administration
Published: 1983-06-16

Substantially Equivalent

Austin Biological Laboratories

FDA 510(k) clearance K830968 for RAPID IDENTIFI-METHOD NEISSERIA KIT, Substantially Equivalent on 1983-06-16. Applicant: Austin Biological Laboratories. Device class: 1.

Clearance details

Applicant: Austin Biological Laboratories
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1983-03-28
Decision date: 1983-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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