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Bioplex 2200 Mmrv Igg It On Bioplex 2200 Multi-Analyte Detection System, Biople…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111072

by Bio-Rad Laboratories

Identifiers

510(k) Number
K111072 FDA 510(k)
FDA Product Code
OPL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3510 FDA 510(k)
Regulation Number
866.3510 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Bioplex 2200 Mmrv Igg It On Bioplex 2200 Multi-Analyte Detection System, Biople… by Bio-Rad Laboratories — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K111072 24 fields · synced Jun 18, 2026