Pace 2 System for Chlamydia Trachomatis

510(k) K920378

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 9 Oct 2026

Documents

510(k) K920378↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK920378	Date29 Apr 1992Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K920378
FDA Product Code: LSK
FDA applicant: Gen-Probe, Inc.

Device Class: Class I
Regulation: 21 CFR Part 866.3120
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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