The following data is part of a premarket notification filed by Micro Media Laboratories with the FDA for Selenite Broth.
Device ID | K834015 |
510k Number | K834015 |
Device Name: | SELENITE BROTH |
Classification | Culture Media, Selective Broth |
Applicant | MICRO MEDIA LABORATORIES 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | JSD |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-21 |
Decision Date | 1983-12-22 |