EBV-CHECK(TM) TEST KIT (IGG)

Antiserum, Cf, Epstein-barr Virus

DIAGNOSTIC TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Ebv-check(tm) Test Kit (igg).

Pre-market Notification Details

Device IDK871373
510k NumberK871373
Device Name:EBV-CHECK(TM) TEST KIT (IGG)
ClassificationAntiserum, Cf, Epstein-barr Virus
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 CodeGNP  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-07
Decision Date1987-06-25

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