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 |