Crp-Wellcotest

by Burroughs Wellcome Co. 510(k)

Active United States

510(k) K771139

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK771139	Date14 Jul 1977Cleared	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Withdrawn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: K771139
FDA Product Code: DCN

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

Other devices from Burroughs Wellcome Co.

Sac-Cel

Class II
Thymune-M

Class II
Toxha Test

Class II
Dac-Cel T4

Class II
Fluorescent Anti. Anti-Human C3

Class II
Cammadisk Digoxin

Class II

See all devices from Burroughs Wellcome Co. →