PMA P050042S015
- Device
- ACHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S015
- Product code
- MZO
- Decision date
- 2011-12-21
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.
Current openFDA PMA Record#
- Device
- ACHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S015
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-12-21
- Decision code
- APPR
- Date received
- 2011-11-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.