FDA applicant

Bionike, Inc.

Simi Valley, CA2 decisions1997–19990 recalls

FDA records 2 decisions for Bionike, Inc. (Simi Valley, CA) from 1997 to 1999: 2 510(k) clearances. Most are in product codes DIS (Enzyme Immunoassay, Barbiturate) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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, clinical toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Bionike, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bionike, 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 “Bionike”

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

Bionike Laboratories, Inc. 6

Bionike, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bionike”