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FDA 510(k)

SYDNEY IVF SPERM CRYOPRESERVATION BUFFER

K-Number: K061371 · 2006-08-17

ApplicantCook Urological, Inc.
Decision Date2006-08-17
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SYDNEY IVF SPERM CRYOPRESERVATION BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2006-08-17 under 510(k) number K061371. 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 SYDNEY IVF SPERM CRYOPRESERVATION BUFFER?

SYDNEY IVF SPERM CRYOPRESERVATION BUFFER is a medical device that received FDA 510(k) clearance on 2006-08-17. The listed applicant is Cook Urological, Inc.. The 510(k) number is K061371.

When did SYDNEY IVF SPERM CRYOPRESERVATION BUFFER receive FDA 510(k) clearance?

SYDNEY IVF SPERM CRYOPRESERVATION BUFFER received FDA 510(k) clearance on 2006-08-17, under 510(k) number K061371.

Who is the listed applicant for SYDNEY IVF SPERM CRYOPRESERVATION BUFFER?

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

What is the FDA product code for SYDNEY IVF SPERM CRYOPRESERVATION BUFFER?

The FDA product code for SYDNEY IVF SPERM CRYOPRESERVATION BUFFER is MQL.

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Other records listing Cook Urological, Inc. as applicant

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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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