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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, Selective And Non-Differential
510(k) Number K810181
Device Name DERMOTOPHYTE TEST MEDIUM
Applicant
Troy Biologicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Troy Biologicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received01/22/1981
Decision Date 02/05/1981
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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