The following data is part of a premarket notification filed by Radiation Technology, Inc. with the FDA for Culture Media For In Vitro Diag. Use.
Device ID | K802892 |
510k Number | K802892 |
Device Name: | CULTURE MEDIA FOR IN VITRO DIAG. USE |
Classification | Culture Media, Non-selective And Non-differential |
Applicant | RADIATION TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-17 |
Decision Date | 1980-12-11 |