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FDA 510(k)

LXN FRUCTOSAMINE TEST SYSTEM

K-Number: K962597 · 1997-06-13

ApplicantLxn Corp.
Decision Date1997-06-13
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LXN FRUCTOSAMINE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lxn Corp.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K962597. 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 LXN FRUCTOSAMINE TEST SYSTEM?

LXN FRUCTOSAMINE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Lxn Corp.. The 510(k) number is K962597.

When did LXN FRUCTOSAMINE TEST SYSTEM receive FDA 510(k) clearance?

LXN FRUCTOSAMINE TEST SYSTEM received FDA 510(k) clearance on 1997-06-13, under 510(k) number K962597.

Who is the listed applicant for LXN FRUCTOSAMINE TEST SYSTEM?

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

What is the FDA product code for LXN FRUCTOSAMINE TEST SYSTEM?

The FDA product code for LXN FRUCTOSAMINE TEST SYSTEM is LCP.

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Other records listing Lxn Corp. 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.

K002688PERSONAL GLUCOSE CONTROL CHARTING SYSTEMK991754GO GLUCOSE MONITORING SYSTEMK990942DUET II GLUCOSE CONTROL MONITORING SYSTEMK973140DUET GLUCOSE CONTROL MONITORING SYSTEMK960034LXN BLOOD GLUCOSE TEST SYSTEMK955629LXN FRUCTOSAMINE TEST

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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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