The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Streptococus Id Plate.
| Device ID | K831349 |
| 510k Number | K831349 |
| Device Name: | STREPTOCOCUS ID PLATE |
| Classification | Kit, Fastidious Organisms |
| Applicant | GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JST |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-25 |
| Decision Date | 1983-05-16 |