Medical Device Manufacturer · US , Grove City , OH

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

20 submissions · 20 cleared · Since 2007
20
Total
20
Cleared
0
Denied

Tosoh Bioscience, Inc. has 20 FDA 510(k) cleared chemistry devices. Based in Grove City, US.

Latest FDA clearance: Oct 2025. Active since 2007.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Tosoh Bioscience, Inc.
20 devices
1-20 of 20
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
Cleared Jun 15, 2012
ST AIA-PACK HOMOCYSTEINE
K121533 · LPS
Chemistry · 22d
Cleared Dec 01, 2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
K111335 · CKG
Chemistry · 203d
Cleared Aug 05, 2011
ST AIA-PACK DHEA-S CALIBRATOR SET
K111762 · JIT
Chemistry · 43d
Cleared Sep 14, 2010
ST AIA-PACK CYSTATIN C, MODEL 025217
K093960 · NDY
Chemistry · 265d
Cleared Aug 27, 2010
ST AIA PACK HBA1C
K100304 · LCP
Chemistry · 205d
Cleared Oct 02, 2009
AIA-PACK RBC FOLATE
K091332 · CGN
Chemistry · 149d
Cleared Sep 16, 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132 · LCP
Chemistry · 512d
Cleared Jun 21, 2007
ST AIA-PACK INTACT PTH ASSAY
K063605 · CEW
Chemistry · 199d
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