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Multi-Allergen Ige Fastscreen V (t1 +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K883371

by 3m Company

Identifiers

510(k) Number
K883371 FDA 510(k)
FDA Product Code
DHB FDA 510(k)
Models / Variants
t1 FDA 510(k)
T3 FDA 510(k)
T5 FDA 510(k)
T7 FDA 510(k)
T10 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)

Multi-Allergen Ige Fastscreen V (t1 +4 more) by 3m Company — Class II — FDA_510K — listed in FDA 510(k) — 5 models — 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) K883371 24 fields · synced Jun 19, 2026