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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K791303
Device Name DORN BLOOD CULTURE COLLECTION TUBE
Applicant
Wadley Institutes of Molecular Medici
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Wadley Institutes of Molecular Medici
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1675
Classification Product Code
JKA  
Date Received07/16/1979
Decision Date 09/17/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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