# Diagnostic Chemicals, Ltd.

- Location (FDA's records): Charlottetown, P.E.I., CA
- FDA decisions: 66 (1994–2007): 66 510(k) clearances
- Product codes: DIC (4), LDP (4), KHS (4), DKJ (3), CDQ (3), JIX (3), CIG (3), JQB (2), JIR (2), KNK (2), CFR (2), CGX (2)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Beckman Instruments, Inc.: 1 (https://510kreport.com/company/beckman-instruments)
- Crestat Diagnostics, Inc.: 1 (https://510kreport.com/company/crestat-diagnostics)
- Syntron Bioresearch, Inc.: 1 (https://510kreport.com/company/syntron-bioresearch)
- Selfcare, Inc.: 1 (https://510kreport.com/company/selfcare)
- Vanguard Biomedical Corp.: 1 (https://510kreport.com/company/vanguard-biomedical)
- Unipath, Ltd.: 1 (https://510kreport.com/company/unipath)

## Firms that cite its devices most
- Hitachi Chemical Diagnostics, Inc.: 2 (https://510kreport.com/company/hitachi-chemical-diagnostics)
- Diazyme Laboratories: 1 (https://510kreport.com/company/diazyme-laboratories)
- Genzyme Diagnostics P.E.I., Inc.: 1 (https://510kreport.com/company/genzyme-diagnostics-pei)
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)
- Siemens Medical Solutions Diagnostics: 1 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Its most-cited devices
- K042362: Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12 (2004), cited by 2
- K972337: Dclare Immunodip Stickfor Microalbuminuria (1997), cited by 1
- K974003: Alanine Aminotransferase-SL Assay Catalogue Number 318-10, 318-30 (1997), cited by 1
- K070383: Enzymatic Creatinine Assay (265 Series) (2007), cited by 1
- K042243: Microalbumin Multi-Calibrator Set (2004), cited by 1
- K042330: Acetaminophen-SL Assay (2005), cited by 1

## Recent decisions
- K070383: Enzymatic Creatinine Assay (265 Series) (Jun 22, 2007)
- K063208: Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7 (Jan 19, 2007)
- K060139: CRP-Advance Assay, Models 250-20, 250-25 (Apr 28, 2006)
- K060140: CRP-Advance Multi Calibrator Set, Model SE-250 (Apr 24, 2006)
- K051757: Calcium Advance Assay, Model 145-20, 145-25, 145-20-91 (Nov 10, 2005)
- K051191: DCL Microalbumin Assay, Model 252-20 (Jul 5, 2005)
- K042330: Acetaminophen-SL Assay (Jan 7, 2005)
- K042329: Salicylate-SL Assay (Dec 27, 2004)

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