510(k) Report

FDA applicant

Reagent Laboratory, Inc.

Mchenry, IL19 decisions1984–19860 recalls

FDA records 19 decisions for Reagent Laboratory, Inc. (Mchenry, IL) from 1984 to 1986: 19 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and JJO (Flame Emission Photometer For Clinical Use). 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 Reagent Laboratory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Reagent Laboratory, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Reagent Laboratory, 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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Other applicant names beginning “Reagent”

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