Fiax Test Kit

by Idt, A Division of Whittaker M.A. Bioproducts 510(k)

Active United States

510(k) K782041

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK782041	Date3 Jan 1979Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number: K782041
FDA Product Code: DHN

Device Class: Class II
Regulation: 21 CFR Part 866.5100
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

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