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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 K871264
Device Name CARIESCREEN LB
Applicant
Apo Diagnostics, Inc.
91 Esna Park Dr.
Unit 2, Markham (Toronto)
Ontario, Canada,  CA L3R 2S2
Applicant Contact JAMES WALKER
Correspondent
Apo Diagnostics, Inc.
91 Esna Park Dr.
Unit 2, Markham (Toronto)
Ontario, Canada,  CA L3R 2S2
Correspondent Contact JAMES WALKER
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received03/31/1987
Decision Date 05/07/1987
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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