FDA 510(k)

InActiv Blue

K-Number: K221547 · 2024-06-11

Decision Date2024-06-11

Product CodeQBD

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

InActiv Blue is the device name listed in this FDA 510(k) record. The listed applicant is Fertipro NV. It received FDA 510(k) clearance on 2024-06-11 under 510(k) number K221547. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InActiv Blue?

InActiv Blue is a medical device that received FDA 510(k) clearance on 2024-06-11. The listed applicant is Fertipro NV. The 510(k) number is K221547.

When did InActiv Blue receive FDA 510(k) clearance?

InActiv Blue received FDA 510(k) clearance on 2024-06-11, under 510(k) number K221547.

Who is the listed applicant for InActiv Blue?

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

What is the FDA product code for InActiv Blue?

The FDA product code for InActiv Blue is QBD.

Other records listing Fertipro NV as applicant

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.

K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.