Paracontrol Abnormal Immunoglobulin Cont

by Diagnostica, Inc. United States 510(k)

510(k) K800398

Product code DEW

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK800398	Date12 Mar 1980Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 11 Oct 2026)

Specification

510(k) · synced 11 Oct 2026

510(k) Number: K800398
FDA Product Code: DEW

Device Class: Class II
Regulation: 21 CFR Part 866.5510
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) K800398 24 fields · synced 11 Oct 2026