ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
FDA 510(k) clearance K231616 · decided 2023-08-31
Clearance details
- K-number
- K231616
- Device name
- ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- Applicant
- Zeus Scientific
- Decision
- Substantially Equivalent
- Date received
- 2023-06-02
- Decision date
- 2023-08-31
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KTL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.