FDA applicant

Dade Chemistry Systems, Inc.

Newark, DE13 decisions1996–19974 recalls

FDA records 13 decisions for Dade Chemistry Systems, Inc. (Newark, DE) from 1996 to 1997: 13 510(k) clearances. Most are in product codes JIT (Calibrator, Secondary) and MMI (Immunoassay Method, Troponin Subunit). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Dade Chemistry Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dade Chemistry Systems, Inc. since 2007.

Recalls per year

1in 2019

2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dade Chemistry Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Dade”

FDA records each applicant name separately; these may or may not be the same firm.

Dade Behring, Inc. 344 Dade, Baxter Travenol Diagnostics, Inc. 44 Dade Microscan, Inc. 40 Dade Intl., Inc. 31 Dade Medical, Inc. 1

Dade Chemistry Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Dade”