FDA applicant
Spectrum Diagnostic, Inc.
FDA records 3 decisions for Spectrum Diagnostic, Inc. (Mchenry, IL) from 1982 to 1983: 3 510(k) clearances. Most are in product codes JTW (System, Transport, Aerobic) and JSM (Culture Media, Non-Propagating Transport). 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 Spectrum Diagnostic, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Spectrum Diagnostic, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Spectrum Diagnostic, 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 “Spectrum”
FDA records each applicant name separately; these may or may not be the same firm.