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FDA 510(k)

Elecsys AFP

K-Number: K220176 · 2022-09-15

ApplicantRoche Diagnostics
Decision Date2022-09-15
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys AFP is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-09-15 under approval number K220176. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys AFP?

Elecsys AFP is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Roche Diagnostics. The 510(k) number is K220176.

When was Elecsys AFP approved by the FDA?

Elecsys AFP received FDA 510(k) clearance on 2022-09-15, under approval number K220176.

What company makes Elecsys AFP?

Elecsys AFP is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys AFP?

The FDA product code for Elecsys AFP is LOJ.

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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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