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FDA 510(k)

HBA1C ENZYMATIC ASSAY

K-Number: K050178 · 2005-06-28

ApplicantGeneral Atomics
Decision Date2005-06-28
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HBA1C ENZYMATIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is General Atomics. It received FDA 510(k) clearance on 2005-06-28 under 510(k) number K050178. 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 HBA1C ENZYMATIC ASSAY?

HBA1C ENZYMATIC ASSAY is a medical device that received FDA 510(k) clearance on 2005-06-28. The listed applicant is General Atomics. The 510(k) number is K050178.

When did HBA1C ENZYMATIC ASSAY receive FDA 510(k) clearance?

HBA1C ENZYMATIC ASSAY received FDA 510(k) clearance on 2005-06-28, under 510(k) number K050178.

Who is the listed applicant for HBA1C ENZYMATIC ASSAY?

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

What is the FDA product code for HBA1C ENZYMATIC ASSAY?

The FDA product code for HBA1C ENZYMATIC ASSAY is LCP.

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Other records listing General Atomics 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.

K082488DIAZYME LP(A) ASSAYK072977DIAZYME APOLIPOPROTEIN A-1 ASSAYK072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSK042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITK033360DIAZYME LITHIUM ENZYMATIC ASSAY KIT

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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