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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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2023-01-04 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K221693.

When was Elecsys Anti-HCV II (08837031190) approved by the FDA?

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

What company makes Elecsys Anti-HCV II (08837031190)?

Elecsys Anti-HCV II (08837031190) is manufactured by Roche Diagnostics.

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

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

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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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