ONE STEP HCG URINE PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

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 Pregnancy Test.

Pre-market Notification Details

• Device ID: K043443
• 510k Number: K043443
• Device Name: ONE STEP HCG URINE PREGNANCY TEST
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19087
• Contact: Howard Mann
• Correspondent: Howard Mann; Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19087
• Product Code: LCX
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-12-14
• Decision Date: 2005-04-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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