Tosoh Bioscience, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 03, 2025

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

K250073 · PDJ

Chemistry · 266d

Cleared Nov 08, 2021

ST AIA-PACK BNP Assay

K211199 · NBC

Chemistry · 200d

Cleared Aug 05, 2021

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

K200904 · PDJ

Chemistry · 486d

Cleared Feb 17, 2016

ST AIA-PACK hsE2 Calibrator Set

K160113 · JIT

Chemistry · 29d

Cleared Dec 18, 2015

ST AIA-PACK PROG III Calibrator Set

K153417 · JIT

Chemistry · 23d

Cleared Oct 26, 2015

ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set,...

K150270 · MRG

Chemistry · 264d

Cleared Jul 02, 2015

ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set

K143075 · CDZ

Chemistry · 248d

Cleared Dec 16, 2014

AIA-PACK C-Peptide Control Set

K143296 · JJX

Chemistry · 29d

Cleared Dec 03, 2014

ST AIA-PACK PROG II Calibrator Set

K143144 · JIT

Chemistry · 30d

Cleared Apr 10, 2014

ST AIA-PACK C-PEPTIDE II CALIBRATOR SET

K140648 · JIT

Chemistry · 28d

Cleared Jan 23, 2014

AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8

K131580 · PDJ

Chemistry · 237d

Cleared Feb 08, 2013

ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET,...

K123131 · MRG

Chemistry · 127d