The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Bacteroides Bile Esculin Gar.
| Device ID | K841222 | 
| 510k Number | K841222 | 
| Device Name: | BACTEROIDES BILE ESCULIN GAR | 
| Classification | Culture Media, Selective And Differential | 
| Applicant | ANAEROBE SYSTEMS 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 | 1984-03-22 | 
| Decision Date | 1984-04-04 |