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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K880038
FOIA Releasable 510(k) K880038
Device Name FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
Applicant
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact LEO BRESSLER
Correspondent
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact LEO BRESSLER
Regulation Number864.7500
Classification Product Code
KHG  
Date Received01/05/1988
Decision Date 04/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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