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FDA 510(k)

EARLY CLEAVAGE MEDIUM (ECM)

K-Number: K033462 · 2004-01-15

ApplicantIrvine Scientific Sales Co., Inc.
Decision Date2004-01-15
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EARLY CLEAVAGE MEDIUM (ECM) is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2004-01-15 under 510(k) number K033462. 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 EARLY CLEAVAGE MEDIUM (ECM)?

EARLY CLEAVAGE MEDIUM (ECM) is a medical device that received FDA 510(k) clearance on 2004-01-15. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K033462.

When did EARLY CLEAVAGE MEDIUM (ECM) receive FDA 510(k) clearance?

EARLY CLEAVAGE MEDIUM (ECM) received FDA 510(k) clearance on 2004-01-15, under 510(k) number K033462.

Who is the listed applicant for EARLY CLEAVAGE MEDIUM (ECM)?

The FDA 510(k) record lists Irvine Scientific Sales Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EARLY CLEAVAGE MEDIUM (ECM)?

The FDA product code for EARLY CLEAVAGE MEDIUM (ECM) is MQL.

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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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