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FDA PMA

Assay, enzyme linked immunosorbent, hepatitis c virus

PMA Number: P090008 · 2019-04-24

ApplicantRoche Diagnostics Corp.
Decision Date2019-04-24
PMA NumberP090008
Product CodeMZO
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Assay, enzyme linked immunosorbent, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2019-04-24. The device is classified under product code MZO. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Assay, enzyme linked immunosorbent, hepatitis c virus?

Assay, enzyme linked immunosorbent, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2019-04-24. The listed applicant is Roche Diagnostics Corp..

When did Assay, enzyme linked immunosorbent, hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, enzyme linked immunosorbent, hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, enzyme linked immunosorbent, hepatitis c virus?

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

What is the FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus?

The FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus is MZO.

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Official Source

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

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