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FDA 510(k)

Optina-4C (MHRC-C1N)

K-Number: K250770 · 2025-09-04

ApplicantOptina Diagnostics, Inc.
Decision Date2025-09-04
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Optina-4C (MHRC-C1N) is a medical device manufactured by Optina Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-09-04 under approval number K250770. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optina-4C (MHRC-C1N)?

Optina-4C (MHRC-C1N) is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Optina Diagnostics, Inc.. The 510(k) number is K250770.

When was Optina-4C (MHRC-C1N) approved by the FDA?

Optina-4C (MHRC-C1N) received FDA 510(k) clearance on 2025-09-04, under approval number K250770.

What company makes Optina-4C (MHRC-C1N)?

Optina-4C (MHRC-C1N) is manufactured by Optina Diagnostics, Inc..

What is the FDA product code for Optina-4C (MHRC-C1N)?

The FDA product code for Optina-4C (MHRC-C1N) is HKI.

Other Devices by Optina Diagnostics, Inc.

K231230Optina-4C (MHRC-C1N)

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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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