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FDA 510(k)

VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010

K-Number: K092107 · 2010-06-15

ApplicantNidacon International AB
Decision Date2010-06-15
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 is the device name listed in this FDA 510(k) record. The listed applicant is Nidacon International AB. It received FDA 510(k) clearance on 2010-06-15 under 510(k) number K092107. 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 VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010?

VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 is a medical device that received FDA 510(k) clearance on 2010-06-15. The listed applicant is Nidacon International AB. The 510(k) number is K092107.

When did VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 receive FDA 510(k) clearance?

VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 received FDA 510(k) clearance on 2010-06-15, under 510(k) number K092107.

Who is the listed applicant for VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010?

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

What is the FDA product code for VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010?

The FDA product code for VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 is MQL.

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Other records listing Nidacon International AB 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.

K023206SPERM CRYOPROTECK022443SPERMASSISTK011607SPERMCATCHK012123NIDOILK011606PURESPERM BUFFERK011346READYSWIM

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Related Devices (Code: MQL)

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.

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

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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