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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 K981555
Device Name DIASCREEN REAGENT STRIPS
Applicant
CHRONIMED, INC.
5182 WEST 76TH ST.
MINNEAPOLIS,  MN  55439
Applicant Contact VICKI FRAWLEY
Correspondent
CHRONIMED, INC.
5182 WEST 76TH ST.
MINNEAPOLIS,  MN  55439
Correspondent Contact VICKI FRAWLEY
Regulation Number864.7675
Classification Product Code
LJX  
Date Received05/01/1998
Decision Date 06/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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