510(k) Report

FDA applicant

New Bay Bioresearch Co., Ltd.

Carlsbad, CA1 decision2007–20074 recalls

FDA records 1 decision for New Bay Bioresearch Co., Ltd. (Carlsbad, CA) in 2007: 1 510(k) clearance. All are in product code KHE (Reagent, Occult Blood). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 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, hematology panel, where it files most

How often FDA has decided New Bay Bioresearch Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2011

2011: 4
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — New Bay Bioresearch Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like New Bay Bioresearch Co., Ltd.’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

Which product codes does it file in?

  • KHEReagent, Occult Blood1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K063693Forsure One Step Fecal Occult Blood (Fob) Screen Card TestNew Bay Bioresearch Co., Ltd. · 20074 recalls

The one decision as New Bay Bioresearch Co., Ltd. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K063693Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part…Mar 21, 2011
  • K063693Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal…Mar 21, 2011
  • K063693Clearview iFOB, Clearview - Clearview iFOB Return Mailer (accessory) Product Part…Mar 21, 2011
  • K063693Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal…Mar 21, 2011