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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 K960855
Device Name PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL
Applicant
Home Diagnostics, Inc.
2600 NW 55th Ct.
Suite #239
Ft Lauderdale,  FL  33309
Applicant Contact VIK BAJNATH
Correspondent
Home Diagnostics, Inc.
2600 NW 55th Ct.
Suite #239
Ft Lauderdale,  FL  33309
Correspondent Contact VIK BAJNATH
Regulation Number862.1345
Classification Product Code
CGA  
Date Received03/01/1996
Decision Date 11/07/1996
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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