FDA applicant

Stephens Scientific

Denville, NJ4 decisions1983–19890 recalls

FDA records 4 decisions for Stephens Scientific (Denville, NJ) from 1983 to 1989: 4 510(k) clearances. Most are in product codes KDX (Solution, Decalcifier, Acid Containing) and KEM (Agent, Clearing). 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, pathology panel, where it files most

How often FDA has decided Stephens Scientific’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stephens Scientific since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Stephens”

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

Stephens Instruments 5 Stephens Mfg. Co. 1

Stephens Scientific

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Stephens”