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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K870231
Device Name KULTSURE
Applicant
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Applicant Contact ALLEN CHAN
Correspondent
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Correspondent Contact ALLEN CHAN
Regulation Number866.2900
Classification Product Code
LIO  
Date Received01/21/1987
Decision Date 02/04/1987
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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