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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 K943432
Device Name HEMOCUE B-GLUCOSE SYSTEM
Applicant
Hemocue, Inc.
23263 Madero, Suite A
Mission Viejo,  CA  92691
Applicant Contact R.J. SLOMOFF
Correspondent
Hemocue, Inc.
23263 Madero, Suite A
Mission Viejo,  CA  92691
Correspondent Contact R.J. SLOMOFF
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
JJE  
Date Received07/15/1994
Decision Date 01/17/1995
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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