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FDA 510(k)

G5 I HBA1C TEST, G5 II HBA1C TEST

K-Number: K041635 · 2004-08-16

ApplicantProvalis Diagnostics , Ltd.
Decision Date2004-08-16
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

G5 I HBA1C TEST, G5 II HBA1C TEST is the device name listed in this FDA 510(k) record. The listed applicant is Provalis Diagnostics , Ltd.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K041635. 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 G5 I HBA1C TEST, G5 II HBA1C TEST?

G5 I HBA1C TEST, G5 II HBA1C TEST is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Provalis Diagnostics , Ltd.. The 510(k) number is K041635.

When did G5 I HBA1C TEST, G5 II HBA1C TEST receive FDA 510(k) clearance?

G5 I HBA1C TEST, G5 II HBA1C TEST received FDA 510(k) clearance on 2004-08-16, under 510(k) number K041635.

Who is the listed applicant for G5 I HBA1C TEST, G5 II HBA1C TEST?

The FDA 510(k) record lists Provalis Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G5 I HBA1C TEST, G5 II HBA1C TEST?

The FDA product code for G5 I HBA1C TEST, G5 II HBA1C TEST is LCP.

Other records listing Provalis Diagnostics , Ltd. 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.

K011933GLYCOSAL II HBA 1C TESTK001392GLYCOSAL HBA1C TEST

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

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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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