PMA P050042S005
- Device
- ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S005
- Product code
- MZO
- Decision date
- 2009-06-23
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT ANTI-HCV ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.
Current openFDA PMA Record#
- Device
- ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S005
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2009-06-23
- Decision code
- APPR
- Date received
- 2009-01-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT ANTI-HCV ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.