510(k) K071219
K071219 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ATHENA MULTI-LYTE GBM TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 2007. The device falls under product code MVJ (Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)), 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 6, 2007
- Date Received
- May 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type