NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST— 510(k) K870117

Name: FDA 510(k) clearance K870117
Creator: U.S. Food and Drug Administration
Published: 1987-03-20

Substantially Equivalent

Pro-Lab, Inc.

FDA 510(k) clearance K870117 for NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST, Substantially Equivalent on 1987-03-20. Applicant: Pro-Lab, Inc.. Device class: 1.

Clearance details

Applicant: Pro-Lab, Inc.
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1987-01-12
Decision date: 1987-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough Ont, CA

Download summary PDF View on FDA.gov ↗

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