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FDA 510(k)

LIQUI-HEME GLYCO A1C ASSAY

K-Number: K031296 · 2004-10-15

ApplicantBiodiagnostic Intl
Decision Date2004-10-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LIQUI-HEME GLYCO A1C ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biodiagnostic Intl. It received FDA 510(k) clearance on 2004-10-15 under 510(k) number K031296. 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 LIQUI-HEME GLYCO A1C ASSAY?

LIQUI-HEME GLYCO A1C ASSAY is a medical device that received FDA 510(k) clearance on 2004-10-15. The listed applicant is Biodiagnostic Intl. The 510(k) number is K031296.

When did LIQUI-HEME GLYCO A1C ASSAY receive FDA 510(k) clearance?

LIQUI-HEME GLYCO A1C ASSAY received FDA 510(k) clearance on 2004-10-15, under 510(k) number K031296.

Who is the listed applicant for LIQUI-HEME GLYCO A1C ASSAY?

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

What is the FDA product code for LIQUI-HEME GLYCO A1C ASSAY?

The FDA product code for LIQUI-HEME GLYCO A1C ASSAY is LCP.

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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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