Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRIME-XV FreezIS DMSO-Free MD

K-Number: K231804 · 2023-11-09

ApplicantFujifilm Irvine Scientific
Decision Date2023-11-09
Product CodeNDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRIME-XV FreezIS DMSO-Free MD is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231804. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIME-XV FreezIS DMSO-Free MD?

PRIME-XV FreezIS DMSO-Free MD is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Fujifilm Irvine Scientific. The 510(k) number is K231804.

When did PRIME-XV FreezIS DMSO-Free MD receive FDA 510(k) clearance?

PRIME-XV FreezIS DMSO-Free MD received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231804.

Who is the listed applicant for PRIME-XV FreezIS DMSO-Free MD?

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

What is the FDA product code for PRIME-XV FreezIS DMSO-Free MD?

The FDA product code for PRIME-XV FreezIS DMSO-Free MD is NDS.

Other records listing Fujifilm Irvine Scientific 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 - NXK241341cryo-GO Vitrification DeviceK233764SSS-NX (Serum Substitute Supplement-NX)K190152Vit Kit- Freeze NX and Vit Kit- Warm NX

Related Devices (Code: NDS)

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.

K232543MSC SFMYocon Biology Technology CompanyK240247“MoFi” Cell Culture Basal MediumDuogenic Stemcells CorporationK201789CT-STOREnergy Delivery Solutions

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.

↑