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FDA 510(k)

Monarch Blood Collection Set

K-Number: K232308 · 2023-12-04

ApplicantThe Monarch Company
Decision Date2023-12-04
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Monarch Blood Collection Set is a medical device manufactured by The Monarch Company. It received FDA 510(k) clearance on 2023-12-04 under approval number K232308. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monarch Blood Collection Set?

Monarch Blood Collection Set is a medical device that received FDA 510(k) clearance on 2023-12-04. It is manufactured by The Monarch Company. The 510(k) number is K232308.

When was Monarch Blood Collection Set approved by the FDA?

Monarch Blood Collection Set received FDA 510(k) clearance on 2023-12-04, under approval number K232308.

What company makes Monarch Blood Collection Set?

Monarch Blood Collection Set is manufactured by The Monarch Company.

What is the FDA product code for Monarch Blood Collection Set?

The FDA product code for Monarch Blood Collection Set is JKA.

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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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