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FDA 510(k)

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS

K-Number: K033674 · 2004-02-09

ApplicantSeradyn, Inc.
Decision Date2004-02-09
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 2004-02-09 under 510(k) number K033674. 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 MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS?

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS is a medical device that received FDA 510(k) clearance on 2004-02-09. The listed applicant is Seradyn, Inc.. The 510(k) number is K033674.

When did MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS receive FDA 510(k) clearance?

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS received FDA 510(k) clearance on 2004-02-09, under 510(k) number K033674.

Who is the listed applicant for MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS?

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

What is the FDA product code for MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS?

The FDA product code for MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS is LCP.

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Other records listing Seradyn, Inc. as applicant

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K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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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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