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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 K861217
Device Name VWF-IX:AG CONTROL PLASMA
Applicant
AMERICAN BIOPRODUCTS CO.
601 NORTH JEFFERSON RD.
PARSIPPANY,  NJ  07054
Applicant Contact LOC B LE
Correspondent
AMERICAN BIOPRODUCTS CO.
601 NORTH JEFFERSON RD.
PARSIPPANY,  NJ  07054
Correspondent Contact LOC B LE
Regulation Number864.7290
Classification Product Code
GGP  
Date Received03/31/1986
Decision Date 05/20/1986
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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