EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA

Epstein-barr Virus, Other

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Epstein-barr Vir Early Anti Diff Igg Clin-elisa.

Pre-market Notification Details

Device IDK921628
510k NumberK921628
Device Name:EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
ClassificationEpstein-barr Virus, Other
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactMary Frick
CorrespondentMary Frick
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-06
Decision Date1992-09-14

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