HSV-CHECK(TM) TEST KIT

Condom

DIAGNOSTIC TECHNOLOGY, INC.

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

Pre-market Notification Details

Device IDK890819
510k NumberK890819
Device Name:HSV-CHECK(TM) TEST KIT
ClassificationCondom
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 CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-17
Decision Date1989-06-20

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