FDA 510(k) Application Details - K000578

Device Classification Name Test, Urine Leukocyte

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510(K) Number K000578
Device Name Test, Urine Leukocyte
Applicant SERIM RESEARCH CORP.
23565 REEDY DR.
ELKHART, IN 46514 US
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Contact ROBERT J CARRICO
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Regulation Number 864.7675

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Classification Product Code LJX
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Date Received 02/22/2000
Decision Date 05/05/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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