510(k) K962469
K962469 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY". The FDA issued a decision of Substantially Equivalent on September 9, 1996. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1996
- Date Received
- June 25, 1996
- 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