FDA applicant

Exact Science, Inc.

Washington, D.C., DC1 decision1990–19900 recalls

FDA records 1 decision for Exact Science, Inc. (Washington, D.C., DC) in 1990: 1 510(k) clearance. All are in product code GKZ (Counter, Differential Cell). No recall is linked to its devices.

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

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Exact Science, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Exact Science, 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 “Exact”

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

Exact Medical Manufacturing, Inc. 9 Exact Imaging, Inc. 4 Exact Sciences Corporation 3 Exact Supplies, Ltd. 1

Exact Science, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Exact”