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Tosoh Bioscience, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K250073 Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ2025-10-03 View
510(k) K211199 ST AIA-PACK BNP AssayNBC2021-11-08 View
510(k) K200904 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ2021-08-05 View
510(k) K160113 ST AIA-PACK hsE2 Calibrator SetJIT2016-02-17 View
510(k) K123131 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 AIMRG2013-02-08 View
510(k) K121533 ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETLPS2012-06-15 View
510(k) K111335 ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321CKG2011-12-01 View
510(k) K111762 ST AIA-PACK DHEA-S CALIBRATOR SETJIT2011-08-05 View
510(k) K093960 ST AIA-PACK CYSTATIN C, MODEL 025217NDY2010-09-14 View
510(k) K100304 ST AIA PACK HBA1CLCP2010-08-27 View
510(k) K091332 AIA-PACK RBC FOLATECGN2009-10-02 View
510(k) K071132 G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8LCP2008-09-16 View
510(k) K063605 ST AIA-PACK INTACT PTH ASSAYCEW2007-06-21 View
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