FDA 510(k)

Vit Kit- Freeze NX and Vit Kit- Warm NX

K-Number: K190152 · 2019-06-21

ApplicantFujifilm Irvine Scientific, Inc.

Decision Date2019-06-21

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Vit Kit- Freeze NX and Vit Kit- Warm NX is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific, Inc.. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K190152. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vit Kit- Freeze NX and Vit Kit- Warm NX?

Vit Kit- Freeze NX and Vit Kit- Warm NX is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Fujifilm Irvine Scientific, Inc.. The 510(k) number is K190152.

When did Vit Kit- Freeze NX and Vit Kit- Warm NX receive FDA 510(k) clearance?

Vit Kit- Freeze NX and Vit Kit- Warm NX received FDA 510(k) clearance on 2019-06-21, under 510(k) number K190152.

Who is the listed applicant for Vit Kit- Freeze NX and Vit Kit- Warm NX?

The FDA 510(k) record lists Fujifilm Irvine Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vit Kit- Freeze NX and Vit Kit- Warm NX?

The FDA product code for Vit Kit- Freeze NX and Vit Kit- Warm NX is MQL.

Other records listing Fujifilm Irvine Scientific, Inc. 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.

K250445Fast Warm - NX K241341cryo-GO Vitrification Device K233764SSS-NX (Serum Substitute Supplement-NX)K231804PRIME-XV FreezIS DMSO-Free MD

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Official Source

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