Accuprobe Staphylococcus Aureus Culture Confirma.

510(k) K902213

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) K902213↗

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	NumberK902213	Date6 Aug 1990Cleared	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Withdrawn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: K902213
FDA Product Code: MCS
FDA applicant: Gen-Probe, Inc.

Device Class: Class I
Regulation: 21 CFR Part 866.3700
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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