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FDA 510(k)

HUMAN SERUM ALBUMIN

K-Number: K991392 · 2000-02-07

ApplicantAdvanced Reproductive Technologies
Decision Date2000-02-07
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HUMAN SERUM ALBUMIN 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 2000-02-07 under 510(k) number K991392. 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 HUMAN SERUM ALBUMIN?

HUMAN SERUM ALBUMIN is a medical device that received FDA 510(k) clearance on 2000-02-07. The listed applicant is Advanced Reproductive Technologies. The 510(k) number is K991392.

When did HUMAN SERUM ALBUMIN receive FDA 510(k) clearance?

HUMAN SERUM ALBUMIN received FDA 510(k) clearance on 2000-02-07, under 510(k) number K991392.

Who is the listed applicant for HUMAN SERUM ALBUMIN?

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 HUMAN SERUM ALBUMIN?

The FDA product code for HUMAN SERUM ALBUMIN is MQL.

Related Clinical Trials

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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 MEDIUMK991379QUINN'S SPERM WASHING MEDIUMK991391PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF

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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