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FDA 510(k)

SPERM WASH MEDIUM, CAT# 2003/2005

K-Number: K000989 · 2000-06-08

ApplicantInvitrocare, Inc.
Decision Date2000-06-08
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPERM WASH MEDIUM, CAT# 2003/2005 is the device name listed in this FDA 510(k) record. The listed applicant is Invitrocare, Inc.. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K000989. 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 SPERM WASH MEDIUM, CAT# 2003/2005?

SPERM WASH MEDIUM, CAT# 2003/2005 is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Invitrocare, Inc.. The 510(k) number is K000989.

When did SPERM WASH MEDIUM, CAT# 2003/2005 receive FDA 510(k) clearance?

SPERM WASH MEDIUM, CAT# 2003/2005 received FDA 510(k) clearance on 2000-06-08, under 510(k) number K000989.

Who is the listed applicant for SPERM WASH MEDIUM, CAT# 2003/2005?

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 SPERM WASH MEDIUM, CAT# 2003/2005?

The FDA product code for SPERM WASH MEDIUM, CAT# 2003/2005 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 # 2007K993484Q-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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