FDA PMA

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

PMA番号：P040005 · 2017-04-12

申請者Agilent Technologies Singapore (International) Pte , Ltd.

決定日2017-04-12

PMA番号P040005

製品コードMVD

デバイスクラスクラス3

診療科U

諮問委員会PA

医療機器の概要

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd.. It received FDA 510(k) clearance on 2017-04-12. The device is classified under product code MVD. It was reviewed by the PA advisory panel.

よくある質問

What is the SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd..

When did SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM receive FDA 510(k) clearance?

The clearance date for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM can be found in the official FDA records.

Who is the listed applicant for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?

The FDA 510(k) record lists Agilent Technologies Singapore (International) Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?

The FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is MVD.

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医療機器の概要

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