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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 K841364
Device Name COAGULATION FACTOR V DEFICIENT SUBSTR
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 Received04/02/1984
Decision Date 04/25/1984
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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