T-SPOT ®.TB
FDA premarket approval P070006/S019 · decided 2023-03-27
Approval details
- PMA number
- P070006
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- T-SPOT ®.TB
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2023-03-06
- Decision date
- 2023-03-27
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- Changes to the incoming QC method for one of the components in a Reagent kit.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.