The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Axsym Holo Tc Reagent Kit, Model 3l83-20; Standard Calibrator Kit, Model 3l83-01; Control Kit, Model 3l83-10.
| Device ID | K062467 |
| 510k Number | K062467 |
| Device Name: | AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Erica Conway |
| Correspondent | Erica Conway AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Product Code | CDD |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-24 |
| Decision Date | 2006-11-22 |
| Summary: | summary |