510(k) K042416
K042416 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ATHENA MULTI-LYTE ANA-II TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on October 8, 2004. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2004
- Date Received
- September 7, 2004
- Clearance Type
- Special
- 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