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

510(k) Premarket Notification
  • 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
Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K931698
Device Name KINGS BAY PRELUDE ONE STEP HCG COMBO KIT
Applicant
King'S Bay Intl., Inc.
1175 Park Center Dr., Suite C
Vista,  CA  92083
Applicant Contact CHARLES YU
Correspondent
King'S Bay Intl., Inc.
1175 Park Center Dr., Suite C
Vista,  CA  92083
Correspondent Contact CHARLES YU
Regulation Number862.1155
Classification Product Code
JHI  
Date Received04/06/1993
Decision Date 11/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-