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 |