510(k) K101319
K101319 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA DSDNA ANTIBODY ELISA". The FDA issued a decision of Substantially Equivalent on December 9, 2010. The device falls under product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2010
- Date Received
- May 11, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type