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FDA 510(k)

DIMENSION VISA HBA1C, MODEL K3105A

K-Number: K102045 · 2011-02-14

ApplicantSiemens Heatlhcare Diagnostics, Inc.
Decision Date2011-02-14
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISA HBA1C, MODEL K3105A is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Heatlhcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-02-14 under 510(k) number K102045. 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 DIMENSION VISA HBA1C, MODEL K3105A?

DIMENSION VISA HBA1C, MODEL K3105A is a medical device that received FDA 510(k) clearance on 2011-02-14. The listed applicant is Siemens Heatlhcare Diagnostics, Inc.. The 510(k) number is K102045.

When did DIMENSION VISA HBA1C, MODEL K3105A receive FDA 510(k) clearance?

DIMENSION VISA HBA1C, MODEL K3105A received FDA 510(k) clearance on 2011-02-14, under 510(k) number K102045.

Who is the listed applicant for DIMENSION VISA HBA1C, MODEL K3105A?

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

What is the FDA product code for DIMENSION VISA HBA1C, MODEL K3105A?

The FDA product code for DIMENSION VISA HBA1C, MODEL K3105A is LCP.

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Other records listing Siemens Heatlhcare Diagnostics, 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.

K102772DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)K100293ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810

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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