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 NumberCR250448
Test Name Easy Healthcare Corporation, easy@Home PdG Urine Test  
Manufacturer NameGuangzhou Decheng Biotechnology Co., Ltd.
Consumer Information Phone Number1(855)822-6999
Test TypePregnanediol Glucuronide
Effective Date08/13/2025
Device Nameeasy@Home PdG Urine Test
510(K) Exempt NumberCR250448
Device Classification NameImmunoassay, Pregnanediol Glucuronide, Over The Counter
Product CodeQKE
Regulation Number862.1620
Panel Name Clinical Chemistry
Applicant
Guangzhou Decheng Biotechnology Co., Ltd.
floor 3/4/5/7, bldg. a1, # 12,
science city, huangpu district
guangzhou,  51066 3
Contactmango huang
Date Received07/21/2025
Decision Date 08/13/2025
-
-