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FDA 510(k)

GLYCOSAL II HBA 1C TEST

K-Number: K011933 · 2001-11-02

ApplicantProvalis Diagnostics , Ltd.
Decision Date2001-11-02
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOSAL II HBA 1C 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 2001-11-02 under 510(k) number K011933. 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 GLYCOSAL II HBA 1C TEST?

GLYCOSAL II HBA 1C TEST is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Provalis Diagnostics , Ltd.. The 510(k) number is K011933.

When did GLYCOSAL II HBA 1C TEST receive FDA 510(k) clearance?

GLYCOSAL II HBA 1C TEST received FDA 510(k) clearance on 2001-11-02, under 510(k) number K011933.

Who is the listed applicant for GLYCOSAL II HBA 1C 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 GLYCOSAL II HBA 1C TEST?

The FDA product code for GLYCOSAL II HBA 1C TEST is LCP.

Related Clinical Trials

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.

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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.

K041635G5 I HBA1C TEST, G5 II HBA1C 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

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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