OSOM HCG-URINE TEST MODEL 101

Visual, Pregnancy Hcg, Prescription Use

WYNTEK DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Hcg-urine Test Model 101.

Pre-market Notification Details

Device IDK974159
510k NumberK974159
Device Name:OSOM HCG-URINE TEST MODEL 101
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant WYNTEK DIAGNOSTICS, INC. 6146 NANCY RIDGE DR., SUITE 101 San Diego,  CA  92121
ContactShu-ching Cheng
CorrespondentShu-ching Cheng
WYNTEK DIAGNOSTICS, INC. 6146 NANCY RIDGE DR., SUITE 101 San Diego,  CA  92121
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-14
Decision Date1997-12-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00742860100154 K974159 000
00742860100086 K974159 000
00742860001017 K974159 000

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