Gen-Probe Aptima Combo 2 Assay

by Gen-Probe 3 variants

510(k) K032554

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 11 Oct 2026

Documents

510(k) K032554↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK032554	Date31 Dec 2003Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K032554
FDA Product Code: LSL
FDA applicant: Gen-Probe, Inc.

Device Class: Class II
Regulation: 21 CFR Part 866.3390
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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