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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, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
510(k) Number K923892
Device Name SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA
Applicant
Smith River Biologicals
Rt. 3
Box 191
Ferrum,  VA  24088
Applicant Contact DEBORAH T FOLEY
Correspondent
Smith River Biologicals
Rt. 3
Box 191
Ferrum,  VA  24088
Correspondent Contact DEBORAH T FOLEY
Regulation Number866.1700
Classification Product Code
JSO  
Date Received08/04/1992
Decision Date 06/21/1993
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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