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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K884993
Device Name VISUAL BLOOD GLUCOSE TEST SYSTEM
Applicant
Diagnostic Systems
454 S. Anderson Rd.
Btc 502
Rock Hill,  SC  29730
Applicant Contact CONSTANCE DUCAR
Correspondent
Diagnostic Systems
454 S. Anderson Rd.
Btc 502
Rock Hill,  SC  29730
Correspondent Contact CONSTANCE DUCAR
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/01/1988
Decision Date 12/29/1988
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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