Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP5N-2, DEPT 09VB ABBOTT PARK, IL 60064 |
PMA Number | P050042 |
Supplement Number | S005 |
Date Received | 01/28/2009 |
Decision Date | 06/23/2009 |
Reclassified Date
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12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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