510(k) K963525
K963525 is an FDA 510(k) premarket notification submitted by Shield Diagnostics, Ltd. for the device "DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT". The FDA issued a decision of Substantially Equivalent on November 7, 1996. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1996
- Date Received
- September 4, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type