The following data is part of a premarket notification filed by Axis-shield Diagnostics Limited with the FDA for Advia Centaur Active-b12 (holotranscobalamin)(ab12) Assay, Advia Centaur Active-b12(ab12) Quality Control, And Advia Centaur Active-b12 (ab12) Master Curve Materials (mcm).
| Device ID | K160757 |
| 510k Number | K160757 |
| Device Name: | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, And ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) |
| Classification | Radioassay, Vitamin B12 |
| Applicant | AXIS-SHIELD DIAGNOSTICS LIMITED THE TECHNOLOGY PARK LUNA PLACE Dundee, GB Dd2 1xa |
| Contact | Claire I. Dora |
| Correspondent | Claire I. Dora AXIS-SHIELD DIAGNOSTICS LIMITED THE TECHNOLOGY PARK LUNA PLACE Dundee, GB Dd2 1xa |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2016-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414603100 | K160757 | 000 |
| 00630414245744 | K160757 | 000 |
| 00630414245737 | K160757 | 000 |
| 00630414245720 | K160757 | 000 |
| 00630414603124 | K160757 | 000 |
| 00630414603117 | K160757 | 000 |