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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Enterobacteriaceae
510(k) Number K912924
Device Name RAMBACH AGAR
Applicant
Rantran, Inc.
2624 Beaver Glen Dr.
Ashland,  VA  23005
Applicant Contact ED RANSOM
Correspondent
Rantran, Inc.
2624 Beaver Glen Dr.
Ashland,  VA  23005
Correspondent Contact ED RANSOM
Regulation Number866.2660
Classification Product Code
JSS  
Date Received07/03/1991
Decision Date 02/28/1992
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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