# Stanbio Laboratory

- Location (FDA's records): Mchenry, IL
- FDA decisions: 47 (1977–2009): 47 510(k) clearances
- Product codes: JHJ (4), GKR (3), JIY (2), CDT (2), LDP (2), DHR (1), CIT (1), KNK (1), CDL (1), DCK (1), DIF (1), CKA (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostic Systems, Inc.: 4 (https://510kreport.com/company/roche-diagnostic-systems)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)

## Firms that cite its devices most
- Ekf-Diagnostic GmbH: 2 (https://510kreport.com/company/ekf-diagnostic)
- Tokyo Boeki Medisys, Inc.: 1 (https://510kreport.com/company/tokyo-boeki-medisys)
- Teco Diagnostics: 1 (https://510kreport.com/company/teco-diagnostics)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Its most-cited devices
- K081719: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System (2008), cited by 2
- K042169: Stanbio Laboratory Sirrus Clinical Chemistry Analyzer (2005), cited by 1
- K032482: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System (2003), cited by 1
- K050283: Creatinine Liquicolor (2005), cited by 1

## Recent decisions
- K090093: Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement System (Jun 10, 2009)
- K081719: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System (Jul 18, 2008)
- K050266: Direct Bilirubin Liquicolor and Total Bilirubin Liquicolor (Jun 30, 2005)
- K050283: Creatinine Liquicolor (Jun 30, 2005)
- K042169: Stanbio Laboratory Sirrus Clinical Chemistry Analyzer (Mar 14, 2005)
- K041155: Wide Range C-Reactive Protein (WR CRP) Assay (Oct 14, 2004)
- K032936: Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol Calibrator (Mar 12, 2004)
- K032932: Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol Calibrator (Mar 10, 2004)

Source page: https://510kreport.com/company/stanbio-laboratory