The following data is part of a premarket notification filed by Mds Laboratories, Inc. with the FDA for Cary Blair Transport Medium.
Device ID | K864237 |
510k Number | K864237 |
Device Name: | CARY BLAIR TRANSPORT MEDIUM |
Classification | Culture Media, Non-propagating Transport |
Applicant | MDS LABORATORIES, INC. 2200 SOUTH SHERIDAN WAY MISSISSAUGA, ONT. L5j 2m4, CA |
Contact | William Gastle |
Correspondent | William Gastle MDS LABORATORIES, INC. 2200 SOUTH SHERIDAN WAY MISSISSAUGA, ONT. L5j 2m4, CA |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-28 |
Decision Date | 1987-03-31 |