# Otsuka Pharmaceutical Co., Ltd.

- Location (FDA's records): North Attleboro, MA
- FDA decisions: 6 (1999–2010): 6 510(k) clearances
- Product codes: CHH (2), MSQ (2), JJQ (1), LYR (1)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Helena Laboratories: 2 (https://510kreport.com/company/helena-laboratories)
- Schiff & Co.: 2 (https://510kreport.com/company/schiff)
- Europa Scientific, Ltd.: 1 (https://510kreport.com/company/europa-scientific)
- Enteric Products, Inc.: 1 (https://510kreport.com/company/enteric-products)
- Alfa Scientific Designs, Inc.: 1 (https://510kreport.com/company/alfa-scientific-designs)

## Firms that cite its devices most
- Meretek Diagnostics, Inc.: 1 (https://510kreport.com/company/meretek-diagnostics)

## Its most-cited devices
- K013371: Ubit-IR300 Infrared Spectrometry System (2001), cited by 3

## Recent decisions
- K092817: Poc-AS10 Auto Sampler (Mar 9, 2010)
- K052716: Rapirun H. Pylori Antibody Detection Kit (Nov 16, 2006)
- K041148: Pocone Infrared Spectrophotometer (Jul 15, 2004)
- K013371: Ubit-IR300 Infrared Spectrometry System (Dec 21, 2001)
- K001032: RLP-Cholesterol Immunoseparation Assay (Jul 24, 2000)
- K991083: RLP Cholesterol Immunoseparation Assay (Aug 20, 1999)

Source page: https://510kreport.com/company/otsuka-pharmaceutical