FDA 510(k) Applications Submitted by Tosoh Bioscience, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K071132 |
04/23/2007 |
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 |
Tosoh BioScience, Inc. |
| K091332 |
05/06/2009 |
AIA-PACK RBC FOLATE |
Tosoh BioScience, Inc. |
| K063605 |
12/04/2006 |
ST AIA-PACK INTACT PTH ASSAY |
Tosoh BioScience, Inc. |
| K100304 |
02/03/2010 |
ST AIA PACK HBA1C |
Tosoh BioScience, Inc. |
| K111335 |
05/12/2011 |
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 |
Tosoh BioScience, Inc. |
| K111762 |
06/23/2011 |
ST AIA-PACK DHEA-S CALIBRATOR SET |
Tosoh BioScience, Inc. |
| K093960 |
12/23/2009 |
ST AIA-PACK CYSTATIN C, MODEL 025217 |
Tosoh BioScience, Inc. |
| K200904 |
04/06/2020 |
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 |
Tosoh Bioscience, Inc. |
| K211199 |
04/22/2021 |
ST AIA-PACK BNP Assay |
Tosoh Bioscience, Inc. |
| K121533 |
05/24/2012 |
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET |
Tosoh BioScience, Inc. |
| K160113 |
01/19/2016 |
ST AIA-PACK hsE2 Calibrator Set |
TOSOH BIOSCIENCE, INC. |
| K150270 |
02/04/2015 |
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 |
TOSOH BIOSCIENCE, INC. |
| K140648 |
03/13/2014 |
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET |
Tosoh BioScience, Inc. |
| K131580 |
05/31/2013 |
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 |
Tosoh BioScience, Inc. |
| K123131 |
10/04/2012 |
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 |
Tosoh BioScience, Inc. |
| K143075 |
10/27/2014 |
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set |
TOSOH BIOSCIENCE, INC. |
| K143144 |
11/03/2014 |
ST AIA-PACK PROG II Calibrator Set |
Tosoh BioScience, Inc. |
| K143296 |
11/17/2014 |
AIA-PACK C-Peptide Control Set |
Tosoh BioScience, Inc. |
| K153417 |
11/25/2015 |
ST AIA-PACK PROG III Calibrator Set |
TOSOH BIOSCIENCE, INC. |
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