# Dade Behring, Inc.

- Location (FDA's records): Newark, DE
- FDA decisions: 344 (1978–2010): 343 510(k) clearances and 1 original PMA approval
- Product codes: LON (37), JIT (29), LRG (23), JIX (18), JPA (12), GKP (9), JWY (8), DLJ (8), JJY (8), MMI (7), JIS (6), CFN (6)
- Predicates its devices cite: 354 (164 its own); citations of its devices by later devices: 299 (164 its own)
- Recalls linked to its devices: 159 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Behring Diagnostics, Inc.: 44 (https://510kreport.com/company/behring-diagnostics)
- E.I. Dupont DE Nemours & Co., Inc.: 41 (https://510kreport.com/company/ei-dupont-de-nemours)
- Dade Intl., Inc.: 15 (https://510kreport.com/company/dade-intl)
- Dade Microscan, Inc.: 14 (https://510kreport.com/company/dade-microscan)
- Beckman Instruments, Inc.: 11 (https://510kreport.com/company/beckman-instruments)
- Roche Diagnostics Corp.: 10 (https://510kreport.com/company/roche-diagnostics)
- Abbott Laboratories: 9 (https://510kreport.com/company/abbott-laboratories)
- Dade Chemistry Systems, Inc.: 8 (https://510kreport.com/company/dade-chemistry-systems)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 69 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Ortho-Clinical Diagnostics, Inc.: 14 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Siemens Healthcare Diagnostics Products GmbH: 10 (https://510kreport.com/company/siemens-healthcare-diagnostics-products)
- Beckman Coulter, Inc.: 5 (https://510kreport.com/company/beckman-coulter)
- Roche Diagnostics Operations (Rdo): 2 (https://510kreport.com/company/roche-diagnostics-operations-rdo)
- Siemens Healthcare Diagnostic Products GmbH: 2 (https://510kreport.com/company/siemens-healthcare-diagnostic-products)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)

## Its most-cited devices
- K012470: Modification to N Protein Standard SL (2001), cited by 16
- K012468: Modification to N/T Protein Control SL (2001), cited by 14
- K033908: N High Sensitivity CRP (2004), cited by 11
- K991385: Dade Behring N High Sensitivity CRP Assay (1999), cited by 8
- K011235: Sysmex Automated Coagulation Analyzer / Model # CA-1500 (2001), cited by 8
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) (2005), cited by 6

## Recent decisions
- K093848: PT-Multi-Calibrator, Model OPAT07 (Dec 20, 2010)
- K081161: Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst (Jul 28, 2008)
- K081249: Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem (Jul 21, 2008)
- K071603: Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) (Jun 25, 2008)
- K071597: Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600 (Jun 4, 2008)
- K073604: Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod (Mar 13, 2008)
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (Feb 26, 2008)
- K073072: Dimension Ahdl Flex Reagent Cartridge, Model: DF48B (Feb 21, 2008)

Source page: https://510kreport.com/company/dade-behring