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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Urine
510(k) Number K950257
Device Name MULTIPLE (IZON DBS & URINE 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 Number866.2660
Classification Product Code
JXA  
Subsequent Product Code
GJE  
Date Received01/23/1995
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
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
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