The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Hemoglobin A1c Reagent Set.
| Device ID | K051200 |
| 510k Number | K051200 |
| Device Name: | HEMOGLOBIN A1C REAGENT SET |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Jian Vaeches |
| Correspondent | Jian Vaeches TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | LCP |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-10 |
| Decision Date | 2005-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001808 | K051200 | 000 |
| 10673486001792 | K051200 | 000 |