ADVIA CENTAUR HCV ASSAY
FDA premarket approval P030056/S010 · decided 2015-07-10
Approval details
- PMA number
- P030056
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR HCV ASSAY
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2015-06-11
- Decision date
- 2015-07-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.