Dermatophytin O

by Diagnostica, Inc. United States 510(k)

510(k) K790671

Product code JXB

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK790671	Date31 May 1979Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 10 Oct 2026)

Specification

510(k) · synced 10 Oct 2026

510(k) Number: K790671
FDA Product Code: JXB

Device Class: Class I
Regulation: 21 CFR Part 866.2660
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K790671 24 fields · synced 10 Oct 2026