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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion-specific, chloride
510(k) Number K900887
Device Name ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. 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 Number862.1170
Classification Product Code
CGZ  
Date Received02/26/1990
Decision Date 05/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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