510(k) K984336
K984336 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE GBM ELISA". The FDA issued a decision of Substantially Equivalent on February 8, 1999. 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. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1999
- Date Received
- December 3, 1998
- 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