510(k) K072135
K072135 is an FDA 510(k) premarket notification submitted by Kronus Market Development Associates, Inc. for the device "KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT". The FDA issued a decision of Substantially Equivalent on November 7, 2007. The device falls under product code NWG (Autoantibodies, Glutamic Acid Decarboxylase (Gad)), 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
- November 7, 2007
- Date Received
- August 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Glutamic Acid Decarboxylase (Gad)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).