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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K854762
Device Name HEPANORM CALIBRATION PLASMA SET
Applicant
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact LOC B.LE,PH.D
Correspondent
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact LOC B.LE,PH.D
Regulation Number864.7525
Classification Product Code
KFF  
Date Received11/27/1985
Decision Date 03/03/1986
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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