The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Lsm Agar.
| Device ID | K822558 |
| 510k Number | K822558 |
| Device Name: | LSM AGAR |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-24 |
| Decision Date | 1982-09-14 |