PREMIER TOXINS A&B, MODEL 616096— 510(k) K993914

Name: FDA 510(k) clearance K993914
Creator: U.S. Food and Drug Administration
Published: 1999-12-10

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K993914 for PREMIER TOXINS A&B, MODEL 616096, Substantially Equivalent on 1999-12-10. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1999-11-17
Decision date: 1999-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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