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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, Single Biochemical Test
510(k) Number K850545
Device Name ACETATE DIFFERENTIAL AGAR
Applicant
Hardy Media
205 W.Montecito St.
Santa Barbara,  CA  93101
Applicant Contact JAY HARDY
Correspondent
Hardy Media
205 W.Montecito St.
Santa Barbara,  CA  93101
Correspondent Contact JAY HARDY
Regulation Number866.2320
Classification Product Code
JSF  
Date Received02/11/1985
Decision Date 03/11/1985
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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