The following data is part of a premarket notification filed by Thyroid Diagnostics, Inc. with the FDA for Glyco-check.
| Device ID | K852111 |
| 510k Number | K852111 |
| Device Name: | GLYCO-CHECK |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | THYROID DIAGNOSTICS, INC. Bedford, MA 01730 |
| Contact | Marshall E Deutsch |
| Correspondent | Marshall E Deutsch THYROID DIAGNOSTICS, INC. Bedford, MA 01730 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-15 |
| Decision Date | 1985-07-05 |