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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinopeptide A, Antigen, Antiserum, Control
510(k) Number K854384
Device Name ASSERACHROM FPA KIT
Applicant
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact B LE
Correspondent
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact B LE
Regulation Number866.5350
Classification Product Code
DAN  
Date Received10/30/1985
Decision Date 02/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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