CHOICE ACCU-TEST PREGNANCY TEST KIT

Kit, Test, Pregnancy, Hcg, Over The Counter

SA SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Choice Accu-test Pregnancy Test Kit.

Pre-market Notification Details

Device IDK974154
510k NumberK974154
Device Name:CHOICE ACCU-TEST PREGNANCY TEST KIT
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
ContactHarbi Shadfan
CorrespondentHarbi Shadfan
SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio,  TX  78240
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-04
Decision Date1997-12-19
Summary:summary

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