510(k) K983420
K983420 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code LKP (Anti-Sm Antibody, Antigen And 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
- November 18, 1998
- Date Received
- September 29, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Sm Antibody, Antigen And Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type