The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Cultura Collection And Transport System.
Device ID | K201674 |
510k Number | K201674 |
Device Name: | Cultura Collection And Transport System |
Classification | Culture Media, Non-propagating Transport |
Applicant | Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
Contact | Alex Bohorquez |
Correspondent | Alex Bohorquez Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-19 |
Decision Date | 2021-03-03 |