SERUM TRANSPORT VIALS, T25/SC, TZ10/SC

Tubes, Vials, Systems, Serum Separators, Blood Collection

NCS DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Serum Transport Vials, T25/sc, Tz10/sc.

Pre-market Notification Details

Device IDK851506
510k NumberK851506
Device Name:SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant NCS DIAGNOSTICS, INC. 130 MATHESON BLVD. E. Mississauga, L4z 1y6,  CA
ContactEd Rayner
CorrespondentEd Rayner
NCS DIAGNOSTICS, INC. 130 MATHESON BLVD. E. Mississauga, L4z 1y6,  CA
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-15
Decision Date1985-06-27

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