The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Gramstain Set.
| Device ID | K821977 |
| 510k Number | K821977 |
| Device Name: | GRAMSTAIN SET |
| Classification | Iodine, Grams |
| Applicant | GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HYI |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-06 |
| Decision Date | 1982-07-22 |