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FDA 510(k)

IVC ONE MEDIUM

K-Number: K000938 · 2000-05-25

ApplicantInvitrocare, Inc.
Decision Date2000-05-25
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IVC ONE MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Invitrocare, Inc.. It received FDA 510(k) clearance on 2000-05-25 under 510(k) number K000938. 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 IVC ONE MEDIUM?

IVC ONE MEDIUM is a medical device that received FDA 510(k) clearance on 2000-05-25. The listed applicant is Invitrocare, Inc.. The 510(k) number is K000938.

When did IVC ONE MEDIUM receive FDA 510(k) clearance?

IVC ONE MEDIUM received FDA 510(k) clearance on 2000-05-25, under 510(k) number K000938.

Who is the listed applicant for IVC ONE MEDIUM?

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

What is the FDA product code for IVC ONE MEDIUM?

The FDA product code for IVC ONE MEDIUM is MQL.

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Other records listing Invitrocare, Inc. 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.

K023222ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12K003751HYALURONIDASE REAGENT, MODEL CAT#2212K001967PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210K001113IVC THREE BLASTOCYST MEDIUM, CAT # 2007K000989SPERM WASH MEDIUM, CAT# 2003/2005K000937IVC TWO 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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