Rai-Trol Elevated Lipids Control

by Reagents Applications, Inc. 510(k)

Active United States

510(k) K915191

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK915191	Date18 Dec 1991Cleared	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Withdrawn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: K915191
FDA Product Code: JJY

Device Class: Class I
Regulation: 21 CFR Part 862.1660
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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