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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood/Plasma Collection Device For Dna Testing
510(k) Number K010328
Device Name MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
Applicant
Izon Business Products, Inc.
520 W. Nyack Rd.
West Nyack,  NY  10994
Applicant Contact JACK WERTZ
Correspondent
Izon Business Products, Inc.
520 W. Nyack Rd.
West Nyack,  NY  10994
Correspondent Contact JACK WERTZ
Regulation Number862.1675
Classification Product Code
PJE  
Date Received02/02/2001
Decision Date 04/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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