510(k) K943291
K943291 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "ANTI DS-DNA". The FDA issued a decision of Substantially Equivalent on Dec 2, 1994. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 1994
- Date Received
- Jul 8, 1994
- 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
- 510(k)