# Wako Chemicals USA, Inc.

- Location (FDA's records): Richmond, VA
- FDA decisions: 124 (1981–2011): 123 510(k) clearances and 1 De Novo grant
- Product codes: JIT (15), DFC (9), JIS (7), JIX (4), JJX (4), KNK (4), CEK (3), CIT (3), JFM (3), CHH (3), DCK (3), JFJ (2)
- Predicates its devices cite: 11 (6 its own); citations of its devices by later devices: 15 (6 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cholestech Corp.: 3 (https://510kreport.com/company/cholestech)
- Wako Pure Chemical Industries, Ltd.: 1 (https://510kreport.com/company/wako-pure-chemical-industries)
- Provalis Diagnostics, Ltd.: 1 (https://510kreport.com/company/provalis-diagnostics)

## Firms that cite its devices most
- Good Biotech Corp.: 3 (https://510kreport.com/company/good-biotech)
- Crestat Diagnostics, Inc.: 2 (https://510kreport.com/company/crestat-diagnostics)
- Sigma Diagnostics, Inc.: 1 (https://510kreport.com/company/sigma-diagnostics)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Randox Laboratories, Ltd.: 1 (https://510kreport.com/company/randox-laboratories)

## Its most-cited devices
- K970985: Wako Total Bilirubin V (1997), cited by 3
- K970986: Wako Direct Bilirubin V (1997), cited by 2
- K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 (2005), cited by 2
- K003342: Wako CRP-UL, CRP-UL Calibrator Set (2001), cited by 2
- K912024: Automated Biochemical Analyzer (WAK0-20R & 30R) (1991), cited by 2
- K062368: Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401 (2007), cited by 1

## Recent decisions
- K100464: Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample Dilution (Feb 23, 2011)
- K080125: Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201 (Jul 18, 2008)
- K080123: Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201 (Jul 17, 2008)
- K061775: Wako L-Type Creatinine-M Test, and Wako Creatinine Calibrator (Feb 23, 2007)
- K062368: Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401 (Jan 31, 2007)
- K053131: Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191 (Dec 30, 2005)
- K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 (Dec 30, 2005)
- DEN050002: Lba Afp-L3, Afp-L3 Calibrator Set, Afp-L3 Control Set and Libasys (May 19, 2005)

Source page: https://510kreport.com/company/wako-chemicals-usa