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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 K834050
Device Name PROTOPATH FACTOR IX ASSAY
Applicant
AMERICAN DADE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN DADE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.7290
Classification Product Code
GGP  
Date Received11/23/1983
Decision Date 02/04/1984
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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