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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K870737
Device Name U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
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 Number862.1660
Classification Product Code
JJT  
Date Received02/25/1987
Decision Date 04/13/1987
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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