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FDA 510(k)

PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF

K-Number: K991391 · 2000-01-10

ApplicantAdvanced Reproductive Technologies
Decision Date2000-01-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Reproductive Technologies. It received FDA 510(k) clearance on 2000-01-10 under 510(k) number K991391. 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 PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF?

PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF is a medical device that received FDA 510(k) clearance on 2000-01-10. The listed applicant is Advanced Reproductive Technologies. The 510(k) number is K991391.

When did PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF receive FDA 510(k) clearance?

PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF received FDA 510(k) clearance on 2000-01-10, under 510(k) number K991391.

Who is the listed applicant for PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF?

The FDA 510(k) record lists Advanced Reproductive Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF?

The FDA product code for PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF is MQL.

Related Clinical Trials

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.

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Other records listing Advanced Reproductive Technologies 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.

K991380OIL FOR TISSUE CULTUREK991395QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUMK991392HUMAN SERUM ALBUMINK991379QUINN'S SPERM WASHING MEDIUM

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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