FDA applicant

Pantex, Div. Bio-Analysis, Inc.

Santa Monica, CA16 decisions1981–20120 recalls

FDA records 16 decisions for Pantex, Div. Bio-Analysis, Inc. (Santa Monica, CA) from 1981 to 2012: 16 510(k) clearances. Most are in product codes CEP (Radioimmunoassay, Luteinizing Hormone) and CDZ (Radioimmunoassay, Testosterones And…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 chemistry panel, where it files most

How often FDA has decided Pantex, Div. Bio-Analysis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Pantex”

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

Pantex 1

Pantex, Div. Bio-Analysis, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Pantex”