The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Axis-shield 3-reagent Homocysteine Assay For Synchron.
| Device ID | K112790 |
| 510k Number | K112790 |
| Device Name: | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee,, GB Dd2 1xa |
| Contact | Karen Hill |
| Correspondent | Karen Hill AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee,, GB Dd2 1xa |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2012-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055845400084 | K112790 | 000 |