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FDA 510(k)

EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED

K-Number: K080473 · 2008-09-03

ApplicantMedicult A/S
Decision Date2008-09-03
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED 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 2008-09-03 under 510(k) number K080473. 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 AND EMBRYOASSIST WITH PHENOL RED?

EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED is a medical device that received FDA 510(k) clearance on 2008-09-03. The listed applicant is Medicult A/S. The 510(k) number is K080473.

When did EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED receive FDA 510(k) clearance?

EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED received FDA 510(k) clearance on 2008-09-03, under 510(k) number K080473.

Who is the listed applicant for EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED?

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 AND EMBRYOASSIST WITH PHENOL RED?

The FDA product code for EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED 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 CUMULASEK061309EMBRYOASSISTK061145SPERMSLOWK060983BIOPSY 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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