The following data is part of a premarket notification filed by Radiation Technology, Inc. with the FDA for Mueller Hinton Agar.
Device ID | K801901 |
510k Number | K801901 |
Device Name: | MUELLER HINTON AGAR |
Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
Applicant | RADIATION TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTZ |
CFR Regulation Number | 866.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-08 |
Decision Date | 1980-08-20 |