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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K864081
Device Name U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
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 Number862.1175
Classification Product Code
CHH  
Date Received10/20/1986
Decision Date 12/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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