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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, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
510(k) Number K861301
Device Name BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
Applicant
Troy Biologicals, Inc.
1238 Rankin St.
Troy,  MI  48083
Applicant Contact ROBERT SCOTT
Correspondent
Troy Biologicals, Inc.
1238 Rankin St.
Troy,  MI  48083
Correspondent Contact ROBERT SCOTT
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received04/07/1986
Decision Date 04/21/1986
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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