510(k) Report

FDA applicant

Applied Biosystems, Inc.

Foster City, CA1 decision2008–20080 recalls

FDA records 1 decision for Applied Biosystems, Inc. (Foster City, CA) in 2008: 1 510(k) clearance. All are in product code NSU (Instrumentation For Clinical Multiplex Test…). 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 Applied Biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Applied Biosystems, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Applied Biosystems, 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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Which product codes does it file in?

  • NSUInstrumentation For Clinical Multiplex Test Systems1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082562Applied Biosystems 7500 Fast DXApplied Biosystems, Inc. · 20082cite it

What has FDA decided for it lately?

  • K082562Applied Biosystems 7500 Fast DXApplied Biosystems, Inc. · 2008

The one decision as Applied Biosystems, Inc. →