INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

ALFA SCIENTIFIC DESIGNS, INC.

The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Pregnancy Urine Mid-stream Test.

Pre-market Notification Details

Device IDK984075
510k NumberK984075
Device Name:INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego,  CA  92121
ContactNaishu Wang
CorrespondentNaishu Wang
ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego,  CA  92121
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-16
Decision Date1999-02-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50096295141547 K984075 000
00667742001117 K984075 000
00677421001116 K984075 000

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