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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K041230
Device Name CLINICAL LABORATORY ANALYZING SYSTEM
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
LFR  
Date Received05/10/2004
Decision Date 05/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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