Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HUMAN SERUM ALBUMIN (HSA)

K-Number: K983584 · 1999-02-08

ApplicantIrvine Scientific Sales Co., Inc.
Decision Date1999-02-08
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HUMAN SERUM ALBUMIN (HSA) is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 1999-02-08 under 510(k) number K983584. 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 (HSA)?

HUMAN SERUM ALBUMIN (HSA) is a medical device that received FDA 510(k) clearance on 1999-02-08. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K983584.

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

HUMAN SERUM ALBUMIN (HSA) received FDA 510(k) clearance on 1999-02-08, under 510(k) number K983584.

Who is the listed applicant for HUMAN SERUM ALBUMIN (HSA)?

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

What is the FDA product code for HUMAN SERUM ALBUMIN (HSA)?

The FDA product code for HUMAN SERUM ALBUMIN (HSA) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Irvine Scientific Sales Co., 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.

K171224Arctic Sperm Cryopreservation MediumK170681Continuous Single Culture -NX (CSCM-NX)K170602Continuous Single Culture-NX Complete (CSCM-NXC)K121572CONTINUOUS SINGLE CULTURE COMPLETEK121128MULTIPURPOSE HANDLING MEDIUMK093273VIT KIT - FREEZE AND THAW

View all 40 devices →

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.

↑