The following data is part of a premarket notification filed by Axis-shield Ltd. with the FDA for Diastat Anti-cardiolipin Iga, Model Fcar 500.
| Device ID | K001981 |
| 510k Number | K001981 |
| Device Name: | DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | AXIS-SHIELD LTD. THE TECHNOLOGY PARK Dundee, Tayside, Scotland, GB Dd21xa |
| Contact | Eileen Mccafferty |
| Correspondent | Eileen Mccafferty AXIS-SHIELD LTD. THE TECHNOLOGY PARK Dundee, Tayside, Scotland, GB Dd21xa |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-29 |
| Decision Date | 2000-08-21 |