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.
Device ID | K851506 |
510k Number | K851506 |
Device Name: | SERUM TRANSPORT VIALS, T25/SC, TZ10/SC |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | NCS DIAGNOSTICS, INC. 130 MATHESON BLVD. E. Mississauga, L4z 1y6, CA |
Contact | Ed Rayner |
Correspondent | Ed Rayner NCS DIAGNOSTICS, INC. 130 MATHESON BLVD. E. Mississauga, L4z 1y6, CA |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-15 |
Decision Date | 1985-06-27 |