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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Analysis, Electrophoretic Hemoglobin
510(k) Number K982426
Device Name SPIFE ALKALINE HEMOGLOBIN
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number864.7440
Classification Product Code
JBD  
Date Received07/13/1998
Decision Date 12/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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