510(k) Report

FDA applicant

Chugai Pharmaceuticals Co., Ltd.

San Diego, CA1 decision1998–19982 recalls

FDA records 1 decision for Chugai Pharmaceuticals Co., Ltd. (San Diego, CA) in 1998: 1 510(k) clearance. All are in product code MDK (Dna-Probe, Reagents, Streptococcal). 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, microbiology panel, where it files most

How often FDA has decided Chugai Pharmaceuticals Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chugai Pharmaceuticals Co., Ltd. since 2007.

Recalls per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Chugai Pharmaceuticals Co., Ltd. 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?

  • MDKDna-Probe, Reagents, Streptococcal1decision

What has FDA decided for it lately?

  • K974572Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820Chugai Pharmaceuticals Co., Ltd. · 19982 recalls

The one decision as Chugai Pharmaceuticals Co., Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K974572Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.Dec 30, 2008
  • K974572Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch…May 2, 2007