The following data is part of a premarket notification filed by Axis-shield Poc As with the FDA for Afinion Hbalc.
| Device ID | K050574 |
| 510k Number | K050574 |
| Device Name: | AFINION HBALC |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | AXIS-SHIELD POC AS P.O. BOX 262069 San Diego, CA 92196 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi AXIS-SHIELD POC AS P.O. BOX 262069 San Diego, CA 92196 |
| Product Code | LCP |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQT |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-07 |
| Decision Date | 2005-07-22 |
| Summary: | summary |