PREMIER BLASTOMYCES— 510(k) K923859

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K923859 for PREMIER BLASTOMYCES, Substantially Equivalent on 1992-10-05. Applicant: Meridian Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code MJL
Device class: Class 2
Regulation: 21 CFR 866.3060
Advisory panel: Microbiology
Date received: 1992-07-31
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST1999-06-25
K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA1998-12-17

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