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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K041234
Device Name HEMOCUE HEMOGLOBIN 201DM 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 Number864.5620
Classification Product Code
GKR  
Date Received05/10/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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