510(k) Report

FDA applicant

Adeza Biomedical

Sunnyvale, CA3 decisions1990–19912 recalls

FDA records 3 decisions for Adeza Biomedical (Sunnyvale, CA) from 1990 to 1991: 3 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and JHI (Visual, Pregnancy Hcg, Prescription Use). 2 recalls are 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 Adeza Biomedical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Adeza Biomedical since 2007.

Recalls per year

1in 2025

2009: 12025: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use1decision
  • JHIVisual, Pregnancy Hcg, Prescription Use1decision
  • LIODevice, Specimen Collection1decision

What has FDA decided for it lately?

  • K911045Oba (TM) ReaderAdeza Biomedical · 1991
  • K911047Oba (TM) Serum HCG AssayAdeza Biomedical · 1991
  • K900225Romcheck Specimen Collection KitAdeza Biomedical · 19902 recalls

All 3 as Adeza Biomedical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K900225The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN…Jan 8, 2025Class II
  • K900225Rapid fFN for the TLi IQ system and specimen collection kit in the following…Dec 15, 2009