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 Kit, Screening, Urine
510(k) Number K950246
Device Name MULTIPLE (IZON URINE COLLECTION KIT)
Applicant
Izon Business Products, Inc.
520 W. Nyack Rd.
West Nyack,  NY  10994
Applicant Contact JACK WERRTZ
Correspondent
Izon Business Products, Inc.
520 W. Nyack Rd.
West Nyack,  NY  10994
Correspondent Contact JACK WERRTZ
Regulation Number866.2660
Classification Product Code
JXA  
Date Received01/20/1995
Decision Date 03/21/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-