510(k) Report

FDA applicant

Thermo Fisher Scientific (Life Technologies Holdin

Singapore, SG1 decision2014–20140 recalls

FDA records 1 decision for Thermo Fisher Scientific (Life Technologies Holdin (Singapore, SG) in 2014: 1 510(k) clearance. All are in product code NSU (Instrumentation For Clinical Multiplex Test…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Thermo Fisher Scientific (Life Technologies Holdin’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Thermo Fisher Scientific (Life Technologies Holdin by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thermo Fisher Scientific (Life…’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

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K141220Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS SoftwareThermo Fisher Scientific (Life Technologies Holdin · 20141cites it

What has FDA decided for it lately?

  • K141220Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS SoftwareThermo Fisher Scientific (Life Technologies Holdin · 2014

The one decision as Thermo Fisher Scientific (Life Technologies Holdin →

Other applicant names beginning “Thermo”

FDA records each applicant name separately; these may or may not be the same firm.

Thermo Fisher Scientific 65Thermo Electron OY 14Thermo Biostar, Inc. 5Thermo Dma, Inc. 4Thermo Temp, Inc. 4Thermo Fisher Scientific (Oxoid Ltd.) 3Thermo Orion 3Thermo Bioanalysis Corp. 2Thermo Fisher Scientific (Nalge Nunc Intl) 1Thermo-Mold Medical Products, Inc. 1Thermo Forma, Inc. 1Thermo Body Wrap Systems, Inc. 1