The following data is part of a premarket notification filed by Anarobe Systems with the FDA for Lysine Iron Agar.
| Device ID | K842853 |
| 510k Number | K842853 |
| Device Name: | LYSINE IRON AGAR |
| Classification | Culture Media, Single Biochemical Test |
| Applicant | ANAROBE SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JSF |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-08-03 |