The following data is part of a premarket notification filed by Isle Media And Sterile Products, Inc. with the FDA for Transport Medium Stuart W/ Charcoal.
Device ID | K791515 |
510k Number | K791515 |
Device Name: | TRANSPORT MEDIUM STUART W/ CHARCOAL |
Classification | Culture Media, Non-propagating Transport |
Applicant | ISLE MEDIA AND STERILE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-08 |
Decision Date | 1979-08-22 |