EBV/VCA-CHECK(TM) ANTIGEN SLIDES

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/vca-check(tm) Antigen Slides.

Pre-market Notification Details

Device IDK863408
510k NumberK863408
Device Name:EBV/VCA-CHECK(TM) ANTIGEN SLIDES
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 Received1986-09-03
Decision Date1986-11-28

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