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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, Non-Propagating Transport
510(k) Number K993812
Device Name CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
Applicant
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Applicant Contact MELISSA M TAYLOR
Correspondent
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Correspondent Contact MELISSA M TAYLOR
Regulation Number866.2390
Classification Product Code
JSM  
Date Received11/10/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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