510(k) K882740
K882740 is an FDA 510(k) premarket notification submitted by Lipogen, Inc. for the device "ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY". The FDA issued a decision of Substantially Equivalent on September 22, 1988. The device falls under product code LKJ (Antinuclear Antibody, Antigen, 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
- September 22, 1988
- Date Received
- July 1, 1988
- Clearance Type
- Traditional
- 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