Gen-Probe Aptima Combo 2 Assay

510(k) K022874

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) K022874↗

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	NumberK022874	Date17 Sep 2002Cleared	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Withdrawn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: K022874
FDA Product Code: JTW
FDA applicant: Gen-Probe, Inc.

Device Class: Class I
Regulation: 21 CFR Part 866.2900
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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