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Medix Biotech Ige Visual Screening Test Kit

by Medix Biotech, Inc. 510(k)

Active United States

510(k) K874281

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874281 Date18 Dec 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DHB
Device Class
Class II
Regulation
21 CFR Part 866.5750
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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