The following data is part of a premarket notification filed by Micro Media Laboratories with the FDA for Mueller-hinton.
Device ID | K811608 |
510k Number | K811608 |
Device Name: | MUELLER-HINTON |
Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
Applicant | MICRO MEDIA LABORATORIES 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 | 1981-06-08 |
Decision Date | 1981-06-25 |