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Platelia Aspergillus Eia, Model 62793

FDA 510(k)

Class I (US FDA 510(k))

510(k) K060641

by Bio-Rad

Identifiers

510(k) Number
K060641 FDA 510(k)
FDA Product Code
NOM FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 866.3040 FDA 510(k)
Regulation Number
866.3040 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Platelia Aspergillus Eia, Model 62793 by Bio-Rad — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K060641 24 fields · synced Jun 18, 2026