The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Microbial Differentiation.
| Device ID | K840031 |
| 510k Number | K840031 |
| Device Name: | MICROBIAL DIFFERENTIATION |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | ANAEROBE SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-05 |
| Decision Date | 1984-03-02 |