Documento fuente o registro público
FDA 510(k) K200839 — APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
FDA 510(k) index record K200839. Device: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module. Applicant as listed: Clever Culture Systems. Decision date: 2021-10-28.
Fuente
"device_name": "APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module"
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
2026-10-31
professional use
FDA 510(k) public index record K200839.
Device name: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module. Applicant as listed: Clever Culture Systems.
Decision date: 2021-10-28. Decision wording: Substantially Equivalent.
Product code: QQY. Regulation: 21 CFR 866.2190. Medical specialty: Microbiology.
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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