The following data is part of a premarket notification filed by Carroll Biological Corp. with the FDA for Mannitol Salt Agar.
| Device ID | K832613 |
| 510k Number | K832613 |
| Device Name: | MANNITOL SALT AGAR |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | CARROLL BIOLOGICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-08 |
| Decision Date | 1983-09-12 |