Vitros Chemistry Products Na + Dt Slides, Model 153 2290 and Dt Calibrator Kit, Model 195 7927

by Ortho-Clinical Diagnostics, Inc.

510(k) K091861

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) K091861↗

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 · Special	NumberK091861	Date3 Sep 2009Cleared	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Withdrawn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: K091861
FDA Product Code: JGS
Models / Variants: 153 2290
Dt Calibrator Kit
Model 195 7927

Device Class: Class II
Regulation: 21 CFR Part 862.1665
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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