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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Factor 4 Radioimmunoassay
510(k) Number K862774
Device Name ASSERACHROM PF4 KIT
Applicant
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact OC B LE
Correspondent
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact OC B LE
Regulation Number864.7695
Classification Product Code
LCO  
Date Received07/22/1986
Decision Date 09/04/1986
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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