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FDA 510(k)

ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE

K-Number: K120615 · 2013-05-15

ApplicantAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen
Decision Date2013-05-15
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen. It received FDA 510(k) clearance on 2013-05-15 under 510(k) number K120615. 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 ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE?

ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE is a medical device that received FDA 510(k) clearance on 2013-05-15. The listed applicant is Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen. The 510(k) number is K120615.

When did ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE receive FDA 510(k) clearance?

ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE received FDA 510(k) clearance on 2013-05-15, under 510(k) number K120615.

Who is the listed applicant for ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE?

The FDA 510(k) record lists Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE?

The FDA product code for ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE is CGA.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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