510(k) Report

FDA applicant

Seradyn, Inc.

Indianapolis, IN30 decisions1988–20071 recall

FDA records 30 decisions for Seradyn, Inc. (Indianapolis, IN) from 1988 to 2007: 30 510(k) clearances. Most are in product codes LCD (Enzyme Immunoassay, Gentamicin) and LEG (Enzyme Immunoassay, Valproic Acid). Its devices cite 10 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Seradyn”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Seradyn, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2007

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

Class I Class II/III not classified

FIG. 1 — Seradyn, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Seradyn, 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?

  • LCDEnzyme Immunoassay, Gentamicin2decisions
  • LEGEnzyme Immunoassay, Valproic Acid2decisions
  • JITCalibrator, Secondary2decisions
  • NWMImmunoassay, Anti-Seizure Drug2decisions
  • LCPAssay, Glycosylated Hemoglobin1decision
  • DEFAlpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control1decision

Also: JJQ (1), KLQ (1), GSA (1), LQN (1), DHR (1), LEH (1).

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K051211QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc. · 20052cite it
  • K924186Lpia-Ferritin AssaySeradyn, Inc. · 19921cites it
  • K070645Seradyn QMS TopiramateSeradyn, Inc. · 20071cites it
  • K023058QMS Digoxin Reagent System on the Abbott Aeroset SystemSeradyn · 20021cites it
  • K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 20071cites it
  • K062204Architect Cortisol AssaySeradyn, Inc. · 20061cites it

What has FDA decided for it lately?

  • K070645Seradyn QMS TopiramateSeradyn, Inc. · 2007
  • K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007
  • K062204Architect Cortisol AssaySeradyn, Inc. · 2006
  • K060998QMS TobramycinSeradyn, Inc. · 2006
  • K060709Multigent GentamicinSeradyn, Inc. · 2006
  • K052826QMS Quinidine. QMS Quinidine CalibratorsSeradyn, Inc. · 2005
  • K051211QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc. · 2005
  • K052815QMS Amikacin ReagentsSeradyn, Inc. · 2005

All 28 as Seradyn, Inc. →All 2 as Seradyn →

What has been recalled?

1 recall linked to its devices; the latest:

  • K050419Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.Dec 20, 2007