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 NumberK192123
Test Name Qingdao Hightop Biotech, HIGHTOP Pregnancy Rapid Test Midstream  
Manufacturer NameQingdao Hightop Biotech Co., Ltd.
Consumer Information Phone Number1(800)319-8684
Test TypeUrine hCG by visual color comparison tests
Effective Date09/18/2019
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K192123
Device Name HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
Applicant
Qingdao Hightop Biotech Co., Ltd.
#369 Hedong Rd., Hi-Tech Industrial Development Zone
Qingdao,  CN 266112
Applicant Contact Allen Lee
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.1155
Classification Product Code
LCX  
Date Received08/06/2019
Decision Date 09/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-