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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-Selective And Differential
510(k) Number K864454
Device Name THERMOSTABLE NUCLEASE TEST AGAR
Applicant
Dimed, Intl.
1955 W. County Rd. B2
St. Paul,  MN  55113
Applicant Contact RICK DILLINGHAM
Correspondent
Dimed, Intl.
1955 W. County Rd. B2
St. Paul,  MN  55113
Correspondent Contact RICK DILLINGHAM
Regulation Number866.2320
Classification Product Code
JSH  
Date Received11/12/1986
Decision Date 11/28/1986
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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