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device pma

device pma

Cleveland Diagnostics, Inc. — IsoPSA Assay (PMA)

November 28, 2025$CODXupdated 5mo ago

community read0 votes

Product code: QRF. Advisory committee: IM. Decision: APPR

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same company · ±60 days · 6

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device recallFujirebio Diagnostics, Inc. device recall (Cls II)Dec 11, 2025
device recallFujirebio Diagnostics, Inc. device recall (Cls II)Dec 11, 2025
device recallFujirebio Diagnostics, Inc. device recall (Cls II)Dec 11, 2025
device recallFujirebio Diagnostics, Inc. device recall (Cls II)Dec 11, 2025

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