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FDA 510(k)

DRX HBA1C - FOR PRESCRIPTION HOME USE

K-Number: K000885 · 2000-09-26

ApplicantMetrika, Inc.
Decision Date2000-09-26
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DRX HBA1C - FOR PRESCRIPTION HOME USE is the device name listed in this FDA 510(k) record. The listed applicant is Metrika, Inc.. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K000885. 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 DRX HBA1C - FOR PRESCRIPTION HOME USE?

DRX HBA1C - FOR PRESCRIPTION HOME USE is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Metrika, Inc.. The 510(k) number is K000885.

When did DRX HBA1C - FOR PRESCRIPTION HOME USE receive FDA 510(k) clearance?

DRX HBA1C - FOR PRESCRIPTION HOME USE received FDA 510(k) clearance on 2000-09-26, under 510(k) number K000885.

Who is the listed applicant for DRX HBA1C - FOR PRESCRIPTION HOME USE?

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

What is the FDA product code for DRX HBA1C - FOR PRESCRIPTION HOME USE?

The FDA product code for DRX HBA1C - FOR PRESCRIPTION HOME USE is LCP.

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Other records listing Metrika, Inc. 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.

K051321INVIEWK033847A1CNOW FOR HOME AND PROFESSIONAL USEK022661A1CNOW FOR HOME USEK020235A1CNOW FOR PROFESSIONAL USEK020234A1CNOW FOR RX HOME USEK000887DRX HBA1C

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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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