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FDA 510(k)

DUET GLUCOSE CONTROL MONITORING SYSTEM

K-Number: K973140 · 1997-10-31

ApplicantLxn Corp.
Decision Date1997-10-31
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DUET GLUCOSE CONTROL MONITORING 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 1997-10-31 under 510(k) number K973140. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUET GLUCOSE CONTROL MONITORING SYSTEM?

DUET GLUCOSE CONTROL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-31. The listed applicant is Lxn Corp.. The 510(k) number is K973140.

When did DUET GLUCOSE CONTROL MONITORING SYSTEM receive FDA 510(k) clearance?

DUET GLUCOSE CONTROL MONITORING SYSTEM received FDA 510(k) clearance on 1997-10-31, under 510(k) number K973140.

Who is the listed applicant for DUET GLUCOSE CONTROL MONITORING 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 DUET GLUCOSE CONTROL MONITORING SYSTEM?

The FDA product code for DUET GLUCOSE CONTROL MONITORING SYSTEM is CGA.

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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 SYSTEMK962597LXN FRUCTOSAMINE TEST SYSTEMK960034LXN BLOOD GLUCOSE TEST SYSTEMK955629LXN FRUCTOSAMINE TEST

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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