The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Architect Homocysteine Reagents, Calibrators And Controls.
| Device ID | K073640 |
| 510k Number | K073640 |
| Device Name: | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Claire Dora |
| Correspondent | Claire Dora AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Product Code | LPS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-04-24 |
| Summary: | summary |