Sero/Tex Crp Test

by Texas Immunology, Inc. 510(k)

Active United States

510(k) K821388

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK821388	Date2 Jul 1982Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
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: K821388
FDA Product Code: DCN

Device Class: Class II
Regulation: 21 CFR Part 866.5270
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

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