510(k) K040291
K040291 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "EL-ANA PROFILES: ANTI-CHROMATIN". The FDA issued a decision of Substantially Equivalent on March 11, 2004. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2004
- Date Received
- February 6, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type