FDA applicant

Bioscreen, Inc.

New York, NY1 decision2004–20040 recalls

FDA records 1 decision for Bioscreen, Inc. (New York, NY) in 2004: 1 510(k) clearance. All are in product code NRF (Material, Quality Control, Semen Analysis). 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 Bioscreen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioscreen, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioscreen, 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 “Bioscreen”

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

Bioscreen Medical, Inc. 1

Bioscreen, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bioscreen”