510(k) K041753
K041753 is an FDA 510(k) premarket notification submitted by Aesku Diagnostics for the device "AESKULISA ENA 6 S". The FDA issued a decision of Substantially Equivalent on July 14, 2004. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Aesku Diagnostics has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2004
- Date Received
- June 29, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractable Antinuclear Antibody, Antigen And Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type