The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Architect Hba1c, Architect Hba1c, And Architect Hba1c.
| Device ID | K121842 |
| 510k Number | K121842 |
| Device Name: | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Claire I Dora |
| Correspondent | Claire I Dora AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-25 |
| Decision Date | 2012-12-12 |
| Summary: | summary |