T-SPOT®.TB Test
FDA premarket approval P070006/S022 · decided 2024-01-11
Approval details
- PMA number
- P070006
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- T-SPOT®.TB Test
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2023-12-11
- Decision date
- 2024-01-11
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- a change in the incoming raw material QC procedures
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.