PMA P050042S011
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S011
- Product code
- MZO
- Decision date
- 2011-05-13
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.
Current openFDA PMA Record#
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S011
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-05-13
- Decision code
- OK30
- Date received
- 2011-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.