The following data is part of a premarket notification filed by Micro Media Laboratories with the FDA for Eosin Methylene Blue Agar (levine).
Device ID | K811610 |
510k Number | K811610 |
Device Name: | EOSIN METHYLENE BLUE AGAR (LEVINE) |
Classification | Culture Media, Selective And Differential |
Applicant | MICRO MEDIA LABORATORIES 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-08 |
Decision Date | 1981-06-25 |