FDA applicant
Reagent Laboratory, Inc.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Reagent”
FDA records each applicant name separately; these may or may not be the same firm.