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FDA 510(k)

ICSI CUMULASE

K-Number: K081639 · 2008-09-19

ApplicantMedicult A/S
Decision Date2008-09-19
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ICSI CUMULASE 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 2008-09-19 under 510(k) number K081639. 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 ICSI CUMULASE?

ICSI CUMULASE is a medical device that received FDA 510(k) clearance on 2008-09-19. The listed applicant is Medicult A/S. The 510(k) number is K081639.

When did ICSI CUMULASE receive FDA 510(k) clearance?

ICSI CUMULASE received FDA 510(k) clearance on 2008-09-19, under 510(k) number K081639.

Who is the listed applicant for ICSI CUMULASE?

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 ICSI CUMULASE?

The FDA product code for ICSI CUMULASE 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 1216K080473EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL REDK061309EMBRYOASSISTK061145SPERMSLOWK060983BIOPSY 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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