The following data is part of a premarket notification filed by Isle Media And Sterile Products, Inc. with the FDA for Martin-lewis Agar.
| Device ID | K800334 |
| 510k Number | K800334 |
| Device Name: | MARTIN-LEWIS AGAR |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | ISLE MEDIA AND STERILE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-14 |
| Decision Date | 1980-03-03 |