510(k) K821576
K821576 is an FDA 510(k) premarket notification submitted by Immuno-Products Industries for the device "ANTINUCLEAR ANTIBODY SCREEN FLOURESC". The FDA issued a decision of Substantially Equivalent on June 10, 1982. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Immuno-Products Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1982
- Date Received
- May 28, 1982
- 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