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FDA 510(k)

SPERMSLOW

K-Number: K061145 · 2006-10-02

ApplicantMedicult A/S
Decision Date2006-10-02
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPERMSLOW is the device name listed in this FDA 510(k) record. The listed applicant is Medicult A/S. It received FDA 510(k) clearance on 2006-10-02 under 510(k) number K061145. 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 SPERMSLOW?

SPERMSLOW is a medical device that received FDA 510(k) clearance on 2006-10-02. The listed applicant is Medicult A/S. The 510(k) number is K061145.

When did SPERMSLOW receive FDA 510(k) clearance?

SPERMSLOW received FDA 510(k) clearance on 2006-10-02, under 510(k) number K061145.

Who is the listed applicant for SPERMSLOW?

The FDA 510(k) record lists Medicult A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPERMSLOW?

The FDA product code for SPERMSLOW is MQL.

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Other records listing Medicult A/S 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.

K080172BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216K081639ICSI CUMULASEK080473EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL REDK061309EMBRYOASSISTK060983BIOPSY MEDIUM, MODEL REF 1062K060699SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)

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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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