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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K851506
Device Name SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
Applicant
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Applicant Contact ED RAYNER
Correspondent
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Correspondent Contact ED RAYNER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/15/1985
Decision Date 06/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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