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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Urine Leukocyte
510(k) Number K971976
Device Name DIASCREEN REAGENT STRIPS
Applicant
Dia-Screen Corp.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact VICKI FRAWLEY
Correspondent
Dia-Screen Corp.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact VICKI FRAWLEY
Regulation Number864.7675
Classification Product Code
LJX  
Subsequent Product Codes
JNA   KQO  
Date Received05/29/1997
Decision Date 06/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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