# Tosoh Bioscience, Inc.

- Location (FDA's records): South San Franciso, CA
- FDA decisions: 21 (1993–2025): 20 510(k) clearances and 1 original PMA approval
- Product codes: JIT (5), PDJ (3), LCP (2), MRG (2), MTF (1), CEW (1), CDZ (1), CKG (1), LPS (1), JJX (1), NBC (1), NDY (1)
- Predicates its devices cite: 18 (3 its own); citations of its devices by later devices: 9 (3 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tosoh Medics, Inc.: 6 (https://510kreport.com/company/tosoh-medics)
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Biokit, S.A.: 1 (https://510kreport.com/company/biokit)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)
- Bayer Diagnostics Corp.: 1 (https://510kreport.com/company/bayer-diagnostics)
- DiaSorin, Inc.: 1 (https://510kreport.com/company/diasorin)

## Firms that cite its devices most
- Sebia: 3 (https://510kreport.com/company/sebia)
- Arkray Factory, Inc.: 2 (https://510kreport.com/company/arkray-factory)
- Nanoentek, Inc.: 1 (https://510kreport.com/company/nanoentek)

## Its most-cited devices
- K131580: Automated Gylcohemoglobin Analyzer HLC-723G8 (2014), cited by 3
- K071132: G8 Automated HPLC Analyzer, Model HLC-723 G8 (2008), cited by 2
- P910065: Aia-Pack Psa (1993), cited by 1
- K111335: ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 (2011), cited by 1
- K200904: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (2021), cited by 1
- 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 AI (2013), cited by 1

## Recent decisions
- K250073: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (Oct 3, 2025)
- K211199: ST AIA-PACK BNP Assay (Nov 8, 2021)
- K200904: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (Aug 5, 2021)
- K160113: ST AIA-PACK hsE2 Calibrator Set (Feb 17, 2016)
- K153417: ST AIA-PACK PROG III Calibrator Set (Dec 18, 2015)
- K150270: 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 (Oct 26, 2015)
- K143075: ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (Jul 2, 2015)
- K143296: AIA-PACK C-Peptide Control Set (Dec 16, 2014)

Source page: https://510kreport.com/company/tosoh-bioscience