510(k) K895997
K895997 is an FDA 510(k) premarket notification submitted by Lipogen, Inc. for the device "RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES". The FDA issued a decision of Substantially Equivalent on November 6, 1989. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Lipogen, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1989
- Date Received
- October 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Rnp Antibody, Antigen And Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type