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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K854358
Device Name EZ DETECH-URINE BLOOD TEST STICKS
Applicant
Self Care Systems, Inc.
1527 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact CONNEALY
Correspondent
Self Care Systems, Inc.
1527 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact CONNEALY
Regulation Number864.6550
Classification Product Code
KHE  
Date Received10/29/1985
Decision Date 04/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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