Anti-Human Kappa Serum

by Diagnostica, Inc. United States 510(k)

510(k) K791284

Product code DFH

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK791284	Date27 Nov 1979Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 9 Oct 2026)

Specification

510(k) · synced 9 Oct 2026

510(k) Number: K791284
FDA Product Code: DFH

Device Class: Class II
Regulation: 21 CFR Part 866.5550
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K791284 24 fields · synced 9 Oct 2026