EVIDENCE PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

SALIVA DIAGNOSTIC SYSTEMS

The following data is part of a premarket notification filed by Saliva Diagnostic Systems with the FDA for Evidence Pregnancy Test.

Pre-market Notification Details

Device IDK962721
510k NumberK962721
Device Name:EVIDENCE PREGNANCY TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant SALIVA DIAGNOSTIC SYSTEMS 15 OAK STREET, SUITE 3 Beverly Farms,  MA  01915
ContactFran White
CorrespondentFran White
SALIVA DIAGNOSTIC SYSTEMS 15 OAK STREET, SUITE 3 Beverly Farms,  MA  01915
Product CodeLCX  
Subsequent Product CodeJHI
Subsequent Product CodeJHJ
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-15
Decision Date1996-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00868926000326 K962721 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.