The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Dnase Test Agar W/toluidine Blue.
| Device ID | K822999 |
| 510k Number | K822999 |
| Device Name: | DNASE TEST AGAR W/TOLUIDINE BLUE |
| Classification | Culture Media, Single Biochemical Test |
| Applicant | GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSF |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-12 |
| Decision Date | 1982-11-16 |