MERIFLUOR(TM) PNEUMOCYSTIS— 510(k) K881608

Name: FDA 510(k) clearance K881608
Creator: U.S. Food and Drug Administration
Published: 1988-08-04

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K881608 for MERIFLUOR(TM) PNEUMOCYSTIS, Substantially Equivalent on 1988-08-04. 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: 1988-04-12
Decision date: 1988-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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