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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, coagulation, automated
510(k) Number K961579
Device Name STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
Applicant
AMERICAN BIOPRODUCTS CO.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Applicant Contact ANDREW LOC B LE, PH.D.
Correspondent
AMERICAN BIOPRODUCTS CO.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Correspondent Contact ANDREW LOC B LE, PH.D.
Regulation Number864.5400
Classification Product Code
GKP  
Date Received04/24/1996
Decision Date 07/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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