EBV/EA-CHECK TM TEST KIT

Epstein-barr Virus, Other

DIAGNOSTIC TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Ebv/ea-check Tm Test Kit.

Pre-market Notification Details

Device IDK903612
510k NumberK903612
Device Name:EBV/EA-CHECK TM TEST KIT
ClassificationEpstein-barr Virus, Other
Applicant DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge,  NY  11788
ContactRobert E Lind
CorrespondentRobert E Lind
DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge,  NY  11788
Product CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-09
Decision Date1990-10-16

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