MERIFLUOR TM PNEUMOCYSTIS MODIFICATION— 510(k) K904400

Name: FDA 510(k) clearance K904400
Creator: U.S. Food and Drug Administration
Published: 1990-10-16

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K904400 for MERIFLUOR TM PNEUMOCYSTIS MODIFICATION, Substantially Equivalent on 1990-10-16. Applicant: Meridian Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code LYF
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1990-09-21
Decision date: 1990-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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