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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K893776
Device Name ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
Applicant
ABBOTT LABORATORIES
1921 HURD DR.
P.O.BOX 152020
IRVING,  TX  75015 -2020
Applicant Contact KEITH MINTER
Correspondent
ABBOTT LABORATORIES
1921 HURD DR.
P.O.BOX 152020
IRVING,  TX  75015 -2020
Correspondent Contact KEITH MINTER
Regulation Number862.2160
Classification Product Code
JJE  
Date Received05/22/1989
Decision Date 08/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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