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FDA 510(k)

Elecsys Anti-HCV II (08837031190)

K-Number: K221693 · 2023-01-04

ApplicantRoche Diagnostics
Decision Date2023-01-04
Product CodeMZO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-HCV II (08837031190) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K221693. The device is classified under product code MZO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Anti-HCV II (08837031190)?

Elecsys Anti-HCV II (08837031190) is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Roche Diagnostics. The 510(k) number is K221693.

When did Elecsys Anti-HCV II (08837031190) receive FDA 510(k) clearance?

Elecsys Anti-HCV II (08837031190) received FDA 510(k) clearance on 2023-01-04, under 510(k) number K221693.

Who is the listed applicant for Elecsys Anti-HCV II (08837031190)?

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

What is the FDA product code for Elecsys Anti-HCV II (08837031190)?

The FDA product code for Elecsys Anti-HCV II (08837031190) is MZO.

Other records listing Roche Diagnostics as applicant

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Related Devices (Code: MZO)

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.

K252424Anti-HCV NextAbbott LaboratoriesPMA P050042Assay, enzyme linked immunosorbent, hepatitis c virusAbbott Laboratories, Inc.PMA P190011Assay, enzyme linked immunosorbent, hepatitis c virusDiaSorin, Inc.PMA P030056Assay, enzyme linked immunosorbent, hepatitis c virusSiemens Healthcare DiagnosticsPMA P080027Assay, enzyme linked immunosorbent, hepatitis c virusOraSure Technologies, Inc.PMA P010021Assay, enzyme linked immunosorbent, hepatitis c virusOrtho-Clinical Diagnostics, Inc.

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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