FDA applicant

Monoclonal Antibodies, Inc.

Mountain View, CA14 decisions1982–19880 recalls

FDA records 14 decisions for Monoclonal Antibodies, Inc. (Mountain View, CA) from 1982 to 1988: 14 510(k) clearances. Most are in product codes CEP (Radioimmunoassay, Luteinizing Hormone) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Monoclonal Antibodies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Monoclonal Antibodies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Monoclonal Antibodies, Inc.

Which product codes does it file in?

What has FDA decided for it lately?