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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Partial Thromboplastin
510(k) Number K941210
Device Name PTT-LT TEST KIT
Applicant
American Bioproducts Co.
5 Century Dr.
Parisppany,  NJ  07054
Applicant Contact ANDREW LOC B LE, PH.D
Correspondent
American Bioproducts Co.
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact ANDREW LOC B LE, PH.D
Regulation Number864.7925
Classification Product Code
GGW  
Date Received03/14/1994
Decision Date 03/21/1995
Decision Substantially Equivalent - Kit (SESK)
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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