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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Microbial Growth
510(k) Number K790297
Device Name DETECTION SYSTEM, MS-2 ELECTROCHEMICAL
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number866.2560
Classification Product Code
JTA  
Date Received02/09/1979
Decision Date 04/26/1979
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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