# Dade Chemistry Systems, Inc.

- Location (FDA's records): Newark, DE
- FDA decisions: 13 (1996–1997): 13 510(k) clearances
- Product codes: JIT (4), MMI (1), JJX (1), JHY (1), DHA (1), LTJ (1), JLW (1), JIW (1), CEC (1), JMG (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 15 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Dade Behring, Inc.: 8 (https://510kreport.com/company/dade-behring)
- Ortho-Clinical Diagnostics, Inc.: 3 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Response Biomedical Corp.: 2 (https://510kreport.com/company/response-biomedical)

## Its most-cited devices
- K973650: Troponin (Trop) Method (1997), cited by 4
- K970343: MMB Method (1997), cited by 3
- K963498: Ferr Flex Reagent Cartridge (1997), cited by 2
- K970336: MMB Calibrator (1997), cited by 1
- K973100: Prostate Specific Antigen (Psa) Calibrator (1997), cited by 1
- K963493: Ferritin Calibrator (1996), cited by 1

## Recent decisions
- K973650: Troponin (Trop) Method (Oct 20, 1997)
- K973099: Prostate Specific Antigen Control (Sep 29, 1997)
- K973100: Prostate Specific Antigen (Psa) Calibrator (Sep 29, 1997)
- K973101: Prostate Specific Antigen Method (Sep 18, 1997)
- K971141: FT4 Method for the Dimension RXL Clinical Chemistry System (Apr 28, 1997)
- K970387: Human Chorionic Gonadotropin Method (Mar 10, 1997)
- K970336: MMB Calibrator (Mar 3, 1997)
- K970393: Thyroid Stimulating Hormone Method (Mar 3, 1997)

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