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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, General Nutrient Broth
510(k) Number K800429
Device Name TRYPTIC SOY BROTH W/C02,CYSTEINE & 1%
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number866.2350
Classification Product Code
JSC  
Date Received02/26/1980
Decision Date 03/19/1980
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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