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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 K780807
Device Name HBF-QUIPLATE METHODOLOGY
Applicant
HELENA LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HELENA LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7440
Classification Product Code
JBD  
Date Received05/04/1978
Decision Date 06/02/1978
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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