510(k) Report

FDA applicant

Perkinelmer Life Sciences, Inc.

Norton, OH2 decisions2002–20041 recall

FDA records 2 decisions for Perkinelmer Life Sciences, Inc. (Norton, OH) from 2002 to 2004: 1 510(k) clearance and 1 De Novo grant. Most are in product codes NQL (System, Test, Amino Acids, Free Carnitines And…) and JNB (Ninhydrin And L-Leucyl-L-Alanine…). 1 recall is linked to its devices.

FDA’s records also spell it “Perkinelmer Life Sciences”.

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 Perkinelmer Life Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Perkinelmer Life Sciences, Inc. since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Perkinelmer Life Sciences, Inc. 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?

  • NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry1decision
  • JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine1decision

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.

  • DEN040002Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970Perkinelmer Life Sciences, Inc. · 20041cites it

What has FDA decided for it lately?

  • DEN040002Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970Perkinelmer Life Sciences, Inc. · 2004
  • K021541Neogram Pku Tandem Mass Spectrometry KitPerkinelmer Life Sciences · 20021 recall

The one decision as Perkinelmer Life Sciences, Inc. →The one decision as Perkinelmer Life Sciences →

What has been recalled?

1 recall linked to its devices; the latest:

  • K021541NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number…Nov 26, 2012Class II

Other applicant names beginning “Perkinelmer”

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

Perkinelmer, Inc. 17Perkinelmer Optoelectronics 2