MERIDIAN EBV-IGG TEST KIT— 510(k) K925689

Name: FDA 510(k) clearance K925689
Creator: U.S. Food and Drug Administration
Published: 1993-10-12

Substantially Equivalent

Fuller Laboratories, Inc.

FDA 510(k) clearance K925689 for MERIDIAN EBV-IGG TEST KIT, Substantially Equivalent on 1993-10-12. Applicant: Fuller Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Fuller Laboratories, Inc.
Product code: Code MCD
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1992-11-12
Decision date: 1993-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

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