510(k) Report

FDA applicant

Schiapparelli Biosystems, Inc.

Fairfield, NJ24 decisions1993–19991 recall

FDA records 24 decisions for Schiapparelli Biosystems, Inc. (Fairfield, NJ) from 1993 to 1999: 24 510(k) clearances. Most are in product codes DIP (Enzyme Immunoassay, Diphenylhydantoin) and KLS (Enzyme Immunoassay, Theophylline). Its devices cite 10 predicates, 0 of them its own earlier devices. 1 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 Schiapparelli Biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Schiapparelli Biosystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Schiapparelli Biosystems, 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?

  • DIPEnzyme Immunoassay, Diphenylhydantoin2decisions
  • KLSEnzyme Immunoassay, Theophylline1decision
  • DLZEnzyme Immunoassay, Phenobarbital1decision
  • KLTEnzyme Immunoassay, Carbamazepine1decision
  • DLJCalibrators, Drug Specific1decision
  • JGYColorimetric Method, Triglycerides1decision

Also: MRR (1), JGJ (1), JIX (1), KHQ (1), DJD (1), JJE (1).

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 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.

  • K931786Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 199322cite it
  • K930104Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 19937cite it
  • K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc. · 19993cite it
  • K944911Ace Iron ReagentSchiapparelli Biosystems, Inc. · 19952cite it
  • K981377Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc. · 19982cite it
  • K971526Ace HDL-C ReagentSchiapparelli Biosystems, Inc. · 19972cite it

What has FDA decided for it lately?

  • K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc. · 1999
  • K981375Ace T Uptake Reagent TU CalibratorsSchiapparelli Biosystems, Inc. · 1998
  • K981377Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc. · 1998
  • K973583Ace Theophylline Reagent, Theo CalibratorsSchiapparelli Biosystems, Inc. · 1997
  • K973582Ace Primidone Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997
  • K973581Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997
  • K973536Ace Phenobarbital Reagent/Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997
  • K973414Ace Phenytoin Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997

All 24 as Schiapparelli Biosystems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K930104Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1…Jan 26, 2006