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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Supplement, Culture Media
510(k) Number K853546
Device Name ABBOTT CATION SUPPLEMENT SOLUTION
Applicant
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015 -2020
Applicant Contact BEVERLY CHAMBERS
Correspondent
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015 -2020
Correspondent Contact BEVERLY CHAMBERS
Regulation Number866.2450
Classification Product Code
JSK  
Date Received08/26/1985
Decision Date 09/06/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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