510(k) K030775
K030775 is an FDA 510(k) premarket notification submitted by Immuno Concepts, N.A. , Ltd. for the device "AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM". The FDA issued a decision of Substantially Equivalent on May 12, 2003. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Immuno Concepts, N.A. , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2003
- Date Received
- March 11, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antinuclear Antibody, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type