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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K852666
Device Name IDENTICULT-AE
Applicant
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Applicant Contact THOMAS W KELLEY
Correspondent
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Correspondent Contact THOMAS W KELLEY
Regulation Number866.2660
Classification Product Code
JTO  
Date Received06/24/1985
Decision Date 07/15/1985
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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