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Document NumberK912440
Test Name HOME DIAGNOSTICS, INC., ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
Manufacturer NameHome Diagnostics, Inc.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date07/17/1991
Device Classification Name Glucose Oxidase, Glucose
510(k) Number K912440
Device Name ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Home Diagnostics, Inc.
51 James Way
Eatontown,  NJ  07724
Applicant Contact Maureen Garner
Correspondent
Home Diagnostics, Inc.
51 James Way
Eatontown,  NJ  07724
Correspondent Contact Maureen Garner
Regulation Number862.1345
Classification Product Code
CGA  
Date Received06/03/1991
Decision Date 07/17/1991
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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