Therachem Anti Convulsanta Theophylline

by Fisher Scientific Co., LLC 510(k)

Active United States

510(k) K810504

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK810504	Date11 Mar 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Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number: K810504
FDA Product Code: DIF

Device Class: Class I
Regulation: 21 CFR Part 862.3280
Advisory Committee: Clinical Toxicology
FDA Decision: SESE Substantially Equivalent

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