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 Automated Urinalysis System
510(k) Number K980047
Device Name URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
Applicant
Yeongdong Pharmaceutical Corp.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact THOMAS J BOUCHARD
Correspondent
Yeongdong Pharmaceutical Corp.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact THOMAS J BOUCHARD
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
JIL   LJX  
Date Received01/06/1998
Decision Date 06/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-