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FDA 510(k)

IVC THREE BLASTOCYST MEDIUM, CAT # 2007

K-Number: K001113 · 2000-06-13

ApplicantInvitrocare, Inc.
Decision Date2000-06-13
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IVC THREE BLASTOCYST MEDIUM, CAT # 2007 is the device name listed in this FDA 510(k) record. The listed applicant is Invitrocare, Inc.. It received FDA 510(k) clearance on 2000-06-13 under 510(k) number K001113. 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 THREE BLASTOCYST MEDIUM, CAT # 2007?

IVC THREE BLASTOCYST MEDIUM, CAT # 2007 is a medical device that received FDA 510(k) clearance on 2000-06-13. The listed applicant is Invitrocare, Inc.. The 510(k) number is K001113.

When did IVC THREE BLASTOCYST MEDIUM, CAT # 2007 receive FDA 510(k) clearance?

IVC THREE BLASTOCYST MEDIUM, CAT # 2007 received FDA 510(k) clearance on 2000-06-13, under 510(k) number K001113.

Who is the listed applicant for IVC THREE BLASTOCYST MEDIUM, CAT # 2007?

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 THREE BLASTOCYST MEDIUM, CAT # 2007?

The FDA product code for IVC THREE BLASTOCYST MEDIUM, CAT # 2007 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#2210K000989SPERM WASH MEDIUM, CAT# 2003/2005K993484Q-HTF, CAT# 2001K000938IVC ONE 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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