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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, blood volume measuring
510(k) Number K964406
Device Name AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
Applicant
DAXOR CORPORATION
350 FIFTH AVE., SUITE 7120
NEW YORK,  NY  10118
Applicant Contact JOSEPH FELDSCHUH
Correspondent
DAXOR CORPORATION
350 FIFTH AVE., SUITE 7120
NEW YORK,  NY  10118
Correspondent Contact JOSEPH FELDSCHUH
Regulation Number864.5950
Classification Product Code
JWO  
Date Received11/04/1996
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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