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Tosoh Bioscience, Inc.

20 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073)Tosoh Bioscience, Inc.2025-10-03
ST AIA-PACK BNP Assay (K211199)Tosoh Bioscience, Inc.2021-11-08
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (K200904)Tosoh Bioscience, Inc.2021-08-05
ST AIA-PACK hsE2 Calibrator Set (K160113)Tosoh Bioscience, Inc.2016-02-17
ST AIA-PACK PROG III Calibrator Set (K153417)Tosoh Bioscience, Inc.2015-12-18
ST 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 AIA-PACK 25-OH Vitamin D Pretreatment Set (K150270)Tosoh Bioscience, Inc.2015-10-26
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (K143075)Tosoh Bioscience, Inc.2015-07-02
AIA-PACK C-Peptide Control Set (K143296)Tosoh Bioscience, Inc.2014-12-16
ST AIA-PACK PROG II Calibrator Set (K143144)Tosoh Bioscience, Inc.2014-12-03
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET (K140648)Tosoh Bioscience, Inc.2014-04-10
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 (K131580)Tosoh Bioscience, Inc.2014-01-23
ST 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 AI (K123131)Tosoh Bioscience, Inc.2013-02-08
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET (K121533)Tosoh Bioscience, Inc.2012-06-15
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 (K111335)Tosoh Bioscience, Inc.2011-12-01
ST AIA-PACK DHEA-S CALIBRATOR SET (K111762)Tosoh Bioscience, Inc.2011-08-05
ST AIA-PACK CYSTATIN C, MODEL 025217 (K093960)Tosoh Bioscience, Inc.2010-09-14
ST AIA PACK HBA1C (K100304)Tosoh Bioscience, Inc.2010-08-27
AIA-PACK RBC FOLATE (K091332)Tosoh Bioscience, Inc.2009-10-02
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 (K071132)Tosoh Bioscience, Inc.2008-09-16
ST AIA-PACK INTACT PTH ASSAY (K063605)Tosoh Bioscience, Inc.2007-06-21

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Every clearance here is in the API, with alerts when new ones post.