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FDA PMA

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PMA 核准號:P950009 · 2022-07-11

決定日期2022-07-11
PMA 編號P950009
產品代碼MNM
器械分類3 類
醫療專科U
諮詢委員會PA

器材摘要

READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED is the device name listed in this FDA 510(k) record. The listed applicant is Bd Diagnostics. It received FDA 510(k) clearance on 2022-07-11. The device is classified under product code MNM. It was reviewed by the PA advisory panel.

常見問題

What is the READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED?

READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED is a medical device that received FDA 510(k) clearance on 2022-07-11. The listed applicant is Bd Diagnostics.

When did READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED receive FDA 510(k) clearance?

The clearance date for READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED can be found in the official FDA records.

Who is the listed applicant for READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED?

The FDA 510(k) record lists Bd Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED?

The FDA product code for READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED is MNM.

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官方來源

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