MERIDIAN EBV-EA TEST KIT

Epstein-barr Virus, Other

FULLER LABORATORIES, INC.

The following data is part of a premarket notification filed by Fuller Laboratories, Inc. with the FDA for Meridian Ebv-ea Test Kit.

Pre-market Notification Details

Device IDK925688
510k NumberK925688
Device Name:MERIDIAN EBV-EA TEST KIT
ClassificationEpstein-barr Virus, Other
Applicant FULLER LABORATORIES, INC. 2478 E. FENDER, UNIT 1 Fullerton,  CA  92631
ContactLee Fuller
CorrespondentLee Fuller
FULLER LABORATORIES, INC. 2478 E. FENDER, UNIT 1 Fullerton,  CA  92631
Product CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-12
Decision Date1993-10-12

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