The following data is part of a premarket notification filed by Hycor Biomedical Ltd. with the FDA for Autostat Ii Anti-cardiolipin Iga Elisa.
| Device ID | K030741 |
| 510k Number | K030741 |
| Device Name: | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN Edinburgh, GB Eh26 Opl |
| Contact | Danielle M Knight |
| Correspondent | Danielle M Knight HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN Edinburgh, GB Eh26 Opl |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-10 |
| Decision Date | 2003-05-01 |