Ind One Step Occult Blood (Fob) Test

by Ind Diagnostics, Inc. 510(k)

Active United States

510(k) K113506

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK113506	Date19 Dec 2012Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K113506
FDA Product Code: KHE

Device Class: Class II
Regulation: 21 CFR Part 864.6550
Advisory Committee: Hematology
FDA Decision: SESE Substantially Equivalent

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Class II