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FDA 510(k)

EMBRYOASSIST

K-Number: K061309 · 2007-02-08

ApplicantMedicult A/S
Decision Date2007-02-08
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EMBRYOASSIST 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 2007-02-08 under 510(k) number K061309. 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 EMBRYOASSIST?

EMBRYOASSIST is a medical device that received FDA 510(k) clearance on 2007-02-08. The listed applicant is Medicult A/S. The 510(k) number is K061309.

When did EMBRYOASSIST receive FDA 510(k) clearance?

EMBRYOASSIST received FDA 510(k) clearance on 2007-02-08, under 510(k) number K061309.

Who is the listed applicant for EMBRYOASSIST?

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 EMBRYOASSIST?

The FDA product code for EMBRYOASSIST 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 REDK061145SPERMSLOWK060983BIOPSY 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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