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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K834031
Device Name FACTOR II DEFICIENT SUBSTRATE PLASMA
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 Number864.7290
Classification Product Code
GGP  
Date Received11/22/1983
Decision Date 12/16/1983
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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