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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K971519
Device Name ASSERACHROM TPA TEST KIT
Applicant
American Bioproducts Co.
5 Century Dr.
Parisppany,  NJ  07054
Applicant Contact ANDREW LOC B LE
Correspondent
American Bioproducts Co.
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact ANDREW LOC B LE
Regulation Number864.7290
Classification Product Code
GGP  
Date Received04/25/1997
Decision Date 08/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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