510(k) K974169
K974169 is an FDA 510(k) premarket notification submitted by Wieslab AB for the device "WIELISA ANTI-GBM TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 1998. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Wieslab AB has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1998
- Date Received
- November 5, 1997
- 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