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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 K020935
Device Name HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
Applicant
Hemocue, Inc.
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact R.J. SLOMOFF
Correspondent
Hemocue, Inc.
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact R.J. SLOMOFF
Regulation Number862.1345
Classification Product Code
CGA  
Date Received03/22/2002
Decision Date 04/03/2002
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
Recalls CDRH Recalls
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