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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Salmonella Spp.
510(k) Number K820996
Device Name SALMONELLA & SHIGELLA GROUPING SERA
Applicant
Fisher Scientific Co., LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fisher Scientific Co., LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3550
Classification Product Code
GRL  
Date Received04/09/1982
Decision Date 05/03/1982
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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