FDA applicant

Dade Microscan, Inc.

West Sacramento, CA40 decisions1996–20052 recalls

FDA records 40 decisions for Dade Microscan, Inc. (West Sacramento, CA) from 1996 to 2005: 40 510(k) clearances. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and LTT (Panels, Test, Susceptibility, Antimicrobial). Its devices cite 20 predicates, 20 of them its own earlier devices. 2 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Dade Microscan, Inc. since 2007.

Recalls per year

2in 2015

2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Dade Microscan, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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 Intl., Inc. 31 Dade Chemistry Systems, Inc. 13 Dade Medical, Inc. 1

Dade Microscan, 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”