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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 K882211
Device Name URISCREEN
Applicant
Diatech Diagnostica , Ltd.
C/O Mackler, Cooper & Gibbs Pc
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Applicant Contact BRUCE F MACKLER
Correspondent
Diatech Diagnostica , Ltd.
C/O Mackler, Cooper & Gibbs Pc
1120 Vermont Ave., NW, Suite 600
Washington,  DC  20005
Correspondent Contact BRUCE F MACKLER
Regulation Number866.2660
Classification Product Code
JXA  
Date Received05/26/1988
Decision Date 09/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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