510(k) K831358
K831358 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "AUTOANTIBODY SCREEN TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1983
- Date Received
- April 26, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5090
- Review Panel
- IM
- Submission Type