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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oncometer, Plasma, For Clinical Use
510(k) Number K863099
Device Name ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact MATT KLAMRZYNSKI
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact MATT KLAMRZYNSKI
Regulation Number862.2720
Classification Product Code
JJK  
Date Received08/13/1986
Decision Date 09/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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