510(k) K030741
K030741 is an FDA 510(k) premarket notification submitted by Hycor Biomedical , Ltd. for the device "AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA". The FDA issued a decision of Substantially Equivalent on May 1, 2003. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Hycor Biomedical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2003
- Date Received
- March 10, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Anticardiolipin Immunological
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type