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FDA 510(k)

ST AIA PACK HBA1C

K-Number: K100304 · 2010-08-27

ApplicantTosoh Bioscience, Inc.
Decision Date2010-08-27
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ST AIA PACK HBA1C is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2010-08-27 under 510(k) number K100304. 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 ST AIA PACK HBA1C?

ST AIA PACK HBA1C is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K100304.

When did ST AIA PACK HBA1C receive FDA 510(k) clearance?

ST AIA PACK HBA1C received FDA 510(k) clearance on 2010-08-27, under 510(k) number K100304.

Who is the listed applicant for ST AIA PACK HBA1C?

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

What is the FDA product code for ST AIA PACK HBA1C?

The FDA product code for ST AIA PACK HBA1C is LCP.

Other records listing Tosoh Bioscience, 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.

K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01K211199ST AIA-PACK BNP AssayK200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8K160113ST AIA-PACK hsE2 Calibrator SetK123131ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AIK121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

View all 13 devices →

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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