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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K862641
Device Name U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
Applicant
U. S. Diagnostics, Inc.
P.O. Box 4522
3443 Miguelito Ct.
San Luis Obispo,  CA  93401
Applicant Contact ROY E SPECK
Correspondent
U. S. Diagnostics, Inc.
P.O. Box 4522
3443 Miguelito Ct.
San Luis Obispo,  CA  93401
Correspondent Contact ROY E SPECK
Regulation Number864.7500
Classification Product Code
KHG  
Date Received07/11/1986
Decision Date 08/21/1986
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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