510(k) K102425
K102425 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 12, 2011. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2011
- Date Received
- August 25, 2010
- 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