Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent

by Ortho-Clinical Diagnostics, Inc.

510(k) K984303

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

510(k) K984303↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK984303	Date28 Jan 1999Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K984303
FDA Product Code: LBR

Device Class: Class I
Regulation: 21 CFR Part 862.1475
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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