The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Glycohemoglobin.
| Device ID | K931183 |
| 510k Number | K931183 |
| Device Name: | GLYCOHEMOGLOBIN |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | Chen |
| Correspondent | Chen TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-11-05 |