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 | ETI-AB-COREK PLUS assay |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285 |
PMA Number | P990045 |
Supplement Number | S021 |
Date Received | 09/18/2017 |
Decision Date | 10/16/2017 |
Withdrawal Date
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10/10/2023 |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Relocation of manufacturing activities related to incoming components. |
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