The following data is part of a premarket notification filed by Axis-shield with the FDA for Diastat Anti-cardiolipin Igg/igm, Model Fcar 600.
| Device ID | K001574 |
| 510k Number | K001574 |
| Device Name: | DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | AXIS-SHIELD THE TECHNOLOGY PARK JUNA PLACE Dundee Tayside, Scotland, GB Dd2 1xa |
| Contact | Eileen A Mccafferty |
| Correspondent | Eileen A Mccafferty AXIS-SHIELD THE TECHNOLOGY PARK JUNA PLACE Dundee Tayside, Scotland, GB Dd2 1xa |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-22 |
| Decision Date | 2000-06-09 |