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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 K000578
Device Name SERIM LEUKOCYTE ESTERASE TEST STRIPS
Applicant
SERIM RESEARCH CORP.
23565 REEDY DR.
ELKHART,  IN  46514
Applicant Contact ROBERT J CARRICO
Correspondent
SERIM RESEARCH CORP.
23565 REEDY DR.
ELKHART,  IN  46514
Correspondent Contact ROBERT J CARRICO
Regulation Number864.7675
Classification Product Code
LJX  
Date Received02/22/2000
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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