FDA PMA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

PMA 번호: P000044 · 2019-06-19

신청자Ortho-Clinical Diagnostics, Inc.

결정일2019-06-19

PMA 번호P000044

제품 코드LOM

의료기기 등급등급 2

의학적 전문분야M

규정 번호21 CFR 8

자문 위원회MI

기기 요약

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-06-19. The device is classified under product code LOM. It was reviewed by the MI advisory panel.

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What is the Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Ortho-Clinical Diagnostics, Inc..

When did Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) receive FDA 510(k) clearance?

The clearance date for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) can be found in the official FDA records.

Who is the listed applicant for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?

The FDA product code for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is LOM.

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