Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back to Search Results
Document NumberCR240570
Test Name Wondfo USA Co., Ltd., Wondfo Ovulation Test Strip  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypeLuteinizing hormone (LH)
Effective Date10/21/2024
Device NameWondfo® Ovulation Test Strip
510(K) Exempt NumberCR240570
Device Classification NameTest, Luteinizing Hormone (Lh), Over The Counter
Product CodeNGE
Regulation Number862.1485
Panel Name Clinical Chemistry
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
# 8 lizhishan rd. science city
guangzhou,  51066 3
Contactkaiyu xiao
Date Received09/26/2024
Decision Date 10/21/2024
-
-