Source document or public record
FDA 510(k) K192271 — Access PCT, Access PCT Calibrators
FDA 510(k) index record K192271. Device: Access PCT, Access PCT Calibrators. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2019-11-26.
Source
"device_name": "Access PCT, Access PCT Calibrators"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K192271.
Device name: Access PCT, Access PCT Calibrators. Applicant as listed: Beckman Coulter, Inc..
Decision date: 2019-11-26. Decision wording: Substantially Equivalent.
Product code: PTF. Regulation: 21 CFR 866.3215. 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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