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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K921344
Device Name THROMBO-CALIBRATOR KIT
Applicant
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact LOC B LE
Correspondent
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact LOC B LE
Regulation Number864.5425
Classification Product Code
GGN  
Date Received03/19/1992
Decision Date 06/09/1992
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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