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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K897158
Device Name ABBOTT COMMANDER PARALLEL PROCESSING CENTER
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Applicant Contact MATT KLAMRZYNSKI
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent Contact MATT KLAMRZYNSKI
Regulation Number862.2750
Classification Product Code
JQW  
Date Received12/26/1989
Decision Date 03/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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