BIOTEST ANTI-EBV RECOMBINANT, EA IGM

Epstein-barr Virus, Other

BIOTEST DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Biotest Diagnostics Corp. with the FDA for Biotest Anti-ebv Recombinant, Ea Igm.

Pre-market Notification Details

Device IDK983842
510k NumberK983842
Device Name:BIOTEST ANTI-EBV RECOMBINANT, EA IGM
ClassificationEpstein-barr Virus, Other
Applicant BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 Denville,  NJ  07834
ContactPatricia E Bonness
CorrespondentPatricia E Bonness
BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 Denville,  NJ  07834
Product CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-30
Decision Date1999-06-09
Summary:summary

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