Tosoh Bioscience, Inc. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) cleared devices by Tosoh Bioscience, Inc. Chemistry ✕
20 devices
Cleared
Oct 03, 2025
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
Chemistry
266d
Cleared
Nov 08, 2021
ST AIA-PACK BNP Assay
Chemistry
200d
Cleared
Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
Chemistry
486d
Cleared
Feb 17, 2016
ST AIA-PACK hsE2 Calibrator Set
Chemistry
29d
Cleared
Dec 18, 2015
ST AIA-PACK PROG III Calibrator Set
Chemistry
23d
Cleared
Oct 26, 2015
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set,...
Chemistry
264d
Cleared
Jul 02, 2015
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
Chemistry
248d
Cleared
Dec 16, 2014
AIA-PACK C-Peptide Control Set
Chemistry
29d
Cleared
Dec 03, 2014
ST AIA-PACK PROG II Calibrator Set
Chemistry
30d
Cleared
Apr 10, 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
Chemistry
28d
Cleared
Jan 23, 2014
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
Chemistry
237d
Cleared
Feb 08, 2013
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET,...
Chemistry
127d
Cleared
Jun 15, 2012
ST AIA-PACK HOMOCYSTEINE
Chemistry
22d
Cleared
Dec 01, 2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
Chemistry
203d
Cleared
Aug 05, 2011
ST AIA-PACK DHEA-S CALIBRATOR SET
Chemistry
43d
Cleared
Sep 14, 2010
ST AIA-PACK CYSTATIN C, MODEL 025217
Chemistry
265d
Cleared
Aug 27, 2010
ST AIA PACK HBA1C
Chemistry
205d
Cleared
Oct 02, 2009
AIA-PACK RBC FOLATE
Chemistry
149d
Cleared
Sep 16, 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
Chemistry
512d
Cleared
Jun 21, 2007
ST AIA-PACK INTACT PTH ASSAY
Chemistry
199d