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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
510(k) Number K782049
Device Name BIOASSAY SYSTEM, MS-2 SERUM
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number862.3450
Classification Product Code
DJB  
Date Received12/08/1978
Decision Date 08/28/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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