CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA— 510(k) K950196

Name: FDA 510(k) clearance K950196
Creator: U.S. Food and Drug Administration
Published: 1995-06-30

Substantially Equivalent

Bioclinical Systems, Inc.

FDA 510(k) clearance K950196 for CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA, Substantially Equivalent on 1995-06-30. Applicant: Bioclinical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Bioclinical Systems, Inc.
Product code: Code JTY
Device class: Class 2
Regulation: 21 CFR 866.2410
Advisory panel: Microbiology
Date received: 1995-01-18
Decision date: 1995-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annapolis Junction, MD, US

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