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FDA 510(k)

SPERM CRYOPROTEC

K-Number: K023206 · 2002-11-08

ApplicantNidacon International AB
Decision Date2002-11-08
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPERM CRYOPROTEC 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 2002-11-08 under 510(k) number K023206. 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 SPERM CRYOPROTEC?

SPERM CRYOPROTEC is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Nidacon International AB. The 510(k) number is K023206.

When did SPERM CRYOPROTEC receive FDA 510(k) clearance?

SPERM CRYOPROTEC received FDA 510(k) clearance on 2002-11-08, under 510(k) number K023206.

Who is the listed applicant for SPERM CRYOPROTEC?

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 SPERM CRYOPROTEC?

The FDA product code for SPERM CRYOPROTEC 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.

K092107VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010K022443SPERMASSISTK011607SPERMCATCHK012123NIDOILK011606PURESPERM 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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