ONE STEP HCG URINE/SERUM TEST

System, Test, Human Chorionic Gonadotropin

Guangzhou Wondfo Biotech Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for One Step Hcg Urine/serum Test.

Pre-market Notification Details

Device IDK072500
510k NumberK072500
Device Name:ONE STEP HCG URINE/SERUM TEST
ClassificationSystem, Test, Human Chorionic Gonadotropin
Applicant Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley,  PA  19067
ContactHoward Mann
CorrespondentHoward Mann
Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley,  PA  19067
Product CodeDHA  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-05
Decision Date2009-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816862021639 K072500 000

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