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Allergen Specific Igg4 Control Sera

FDA 510(k)

Class II (US FDA 510(k))

510(k) K870153

by 3m Company

Identifiers

510(k) Number
K870153 FDA 510(k)
FDA Product Code
DHB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5750 FDA 510(k)
Regulation Number
866.5750 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Allergen Specific Igg4 Control Sera by 3m Company — Class II — 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
3m Company

Sources (1)

  • FDA 510(k) K870153 24 fields · synced Jun 18, 2026