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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood, Occult, Colorimetric, In Urine
510(k) Number K893894
Device Name CHARISE CHARLES REAGENT BLOOD STRIPS
Applicant
LEE IMPORT DOMESTIC CONSULTING
3049 GREENMOUNT RD.
ORLANDO,  FL  32806
Applicant Contact LAVAR LEE
Correspondent
LEE IMPORT DOMESTIC CONSULTING
3049 GREENMOUNT RD.
ORLANDO,  FL  32806
Correspondent Contact LAVAR LEE
Regulation Number864.6550
Classification Product Code
JIO  
Date Received05/30/1989
Decision Date 07/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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