510(k) K231616
K231616 is an FDA 510(k) premarket notification submitted by Zeus Scientific for the device "ZEUS IFA(TM) nDNA Test System, ZEUS dIFine". The FDA issued a decision of Substantially Equivalent on August 31, 2023. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Zeus Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2023
- Date Received
- June 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Dna Indirect Immunofluorescent Solid Phase
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type