510(k) K974478
K974478 is an FDA 510(k) premarket notification submitted by Immuno Concepts, Inc. for the device "IMMUNO CONCEPTS ANCA TEST SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 9, 1998. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Immuno Concepts, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1998
- Date Received
- November 26, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type