510(k) K073590
K073590 is an FDA 510(k) premarket notification submitted by Kronus Market Development Associates, Inc. for the device "KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 10, 2008. The device falls under product code OIF (Tyrosine Phosphatase (Ia-2) Autoantibody Assay), a Class II device regulated under 21 CFR 866.5660. Kronus Market Development Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2008
- Date Received
- December 20, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tyrosine Phosphatase (Ia-2) Autoantibody Assay
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).