Rapid Diag. System for Mycobacterium Gordonae

510(k) K890089

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 12 Oct 2026

Documents

510(k) K890089↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK890089	Date13 Mar 1989Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 12 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K890089
FDA Product Code: LQF
FDA applicant: Gen-Probe, Inc.

Device Class: Class I
Regulation: 21 CFR Part 866.3370
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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