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FDA 510(k)

GLYCABEN

K-Number: K893453 · 1989-10-23

ApplicantExocell, Inc.
Decision Date1989-10-23
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCABEN is the device name listed in this FDA 510(k) record. The listed applicant is Exocell, Inc.. It received FDA 510(k) clearance on 1989-10-23 under 510(k) number K893453. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCABEN?

GLYCABEN is a medical device that received FDA 510(k) clearance on 1989-10-23. The listed applicant is Exocell, Inc.. The 510(k) number is K893453.

When did GLYCABEN receive FDA 510(k) clearance?

GLYCABEN received FDA 510(k) clearance on 1989-10-23, under 510(k) number K893453.

Who is the listed applicant for GLYCABEN?

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

What is the FDA product code for GLYCABEN?

The FDA product code for GLYCABEN is LCP.

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 Exocell, 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.

K980888GLYCACORK894423ACC.U.DIALK891544DIALBUMINK884146ALBUWELL

Related Devices (Code: LCP)

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

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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