Documento fuente o registro público
FDA 510(k) K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
FDA 510(k) index record K202343. Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2020-11-16.
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"device_name": "MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K202343.
Device name: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ). Applicant as listed: Beckman Coulter, Inc..
Decision date: 2020-11-16. Decision wording: Substantially Equivalent.
Product code: LTT. Regulation: 21 CFR 866.1640. 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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