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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 K992988
Device Name PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
Applicant
Home Diagnostics, Inc.
24oo NW 55th Ct.
Fort Lauderdale,  FL  33309
Applicant Contact KAREN DEVINCENT
Correspondent
Home Diagnostics, Inc.
24oo NW 55th Ct.
Fort Lauderdale,  FL  33309
Correspondent Contact KAREN DEVINCENT
Regulation Number862.1345
Classification Product Code
CGA  
Date Received09/03/1999
Decision Date 09/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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