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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 K961312
Device Name HEMOCUE B-HEMOGLOBIN SYSTEM
Applicant
HEMOCUE, INC.
C/O ROBERT JOEL SLOMOF
9229 CRANFORD DRIVE
POTOMAC,  MD  20854
Applicant Contact ROBERT J SLOMOF
Correspondent
HEMOCUE, INC.
C/O ROBERT JOEL SLOMOF
9229 CRANFORD DRIVE
POTOMAC,  MD  20854
Correspondent Contact ROBERT J SLOMOF
Regulation Number864.5620
Classification Product Code
GKR  
Date Received04/04/1996
Decision Date 09/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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