Dac-Cel T3 Uptake

by Burroughs Wellcome Co. 510(k)

Active United States

510(k) K810212

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK810212	Date10 Feb 1981Cleared	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Withdrawn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 11 Oct 2026.

Specification

510(k)

510(k) Number: K810212
FDA Product Code: KHQ

Device Class: Class II
Regulation: 21 CFR Part 862.1715
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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