Documento fuente o registro público
FDA 510(k) K223608 — GEM Premier 7000 with IQM3
FDA 510(k) index record K223608. Device: GEM Premier 7000 with IQM3. Applicant as listed: Instrumentation Laboratory Company. Decision date: 2023-08-10.
Fuente
"device_name": "GEM Premier 7000 with IQM3"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-29
professional use
FDA 510(k) public index record K223608.
Device name: GEM Premier 7000 with IQM3. Applicant as listed: Instrumentation Laboratory Company.
Decision date: 2023-08-10. Decision wording: Substantially Equivalent.
Product code: CHL. Regulation: 21 CFR 862.1120. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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