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FDA PMA

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

PMA Number: P030024 · 2019-06-19

ApplicantOrtho-Clinical Diagnostics
Decision Date2019-06-19
PMA NumberP030024
Product CodeLOM
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

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. 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.

Frequently Asked Questions

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.

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 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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