# Hemagen Diagnostics, Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 52 (1986–2004): 52 510(k) clearances
- Product codes: LLL (16), MSV (3), DCK (3), MOB (3), MID (3), DHR (2), JIX (2), DHN (2), CDQ (2), CFR (2), KHS (1), CJY (1)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 11 (8 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
- Scimedx Corp.: 4 (https://510kreport.com/company/scimedx)
- Electro-Nucleonics Laboratories, Inc.: 1 (https://510kreport.com/company/electro-nucleonics-laboratories)
- Atlantic Antibodies: 1 (https://510kreport.com/company/atlantic-antibodies)

## Firms that cite its devices most
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Henage Diagnostics, Inc.: 1 (https://510kreport.com/company/henage-diagnostics)

## Its most-cited devices
- K932373: Hemagen Cardiolipin Antibody Kit (Eia METHOD0 (1993), cited by 4
- K944288: Hemagen C-Reactive Protein Kit (Eia Method) (1994), cited by 2
- K855221: Seratest RF (Hemagglutination) Kit (1986), cited by 2
- K941840: Hemagen Acl Iga Calibrator (1994), cited by 2
- K930272: Hemagen Chagas' Kit (Eia Method) (1995), cited by 1

## Recent decisions
- K041051: Raichem Bun Rate Reagent (Liquid) (Jun 30, 2004)
- K041052: Raichem Glucose UV (Liquid) (Jun 30, 2004)
- K041009: Raichem Calcium (Ocpc) Liquid Reagent (Jun 25, 2004)
- K031101: Raichem Assayed Control Serum Level 1 & 2 (Jun 16, 2003)
- K023784: Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira Anaylzer (Dec 24, 2002)
- K022772: Raichem LDL-Cholesterol Direct Reagent (Sep 17, 2002)
- K022767: Raichem Lipid Calibrator (Sep 3, 2002)
- K021194: Raichem CRP High Sensitivity Test System (Jul 29, 2002)

Source page: https://510kreport.com/company/hemagen-diagnostics