• 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 NumberCR260334
Test Name Phamatech, Inc., QuickScreen At Home Digital Ovulation Test  
Manufacturer NameHangzhou AllTest Biotech Co., Ltd.
Consumer Information Phone Number1(800)635-5840
Test TypeLuteinizing hormone (LH)
Effective Date06/12/2026
Device NameQuickScreen At Home Digital Ovulation Test
510(K) Exempt NumberCR260334
Panel Name Clinical Chemistry
Applicant
Hangzhou AllTest Biotech Co., Ltd.
#550 yinhai st.
hangzhou economic & technologi
hangzhou,  31001 8
Contactrosa wu
Date Received04/21/2026
Decision Date 06/12/2026
-
-