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 Urinalysis Controls (Assayed And Unassayed)
510(k) Number K843565
Device Name KOVA TROL I,II, III HUMAN URINE-DRIED
Applicant
ICL SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ICL SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJW  
Date Received09/10/1984
Decision Date 10/05/1984
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
-
-