Wiener Lab.fosfatemia UV, Models 1X100 Ml Cat.n 1382321, 4X20 Ml Cat.n 1009311

by Wiener Laboratories Saic

510(k) K013095

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

510(k) K013095↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK013095	Date16 Nov 2001Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K013095
FDA Product Code: CEO

Device Class: Class I
Regulation: 21 CFR Part 862.1580
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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