Skip to content

Simplexa C. difficile Direct - Simplexa C. difficile Positive Control Pack

by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC

510(k) K163085

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163085 Date14 Feb 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OZN
Models / Variants
Simplexa C. difficile Positive Control Pack
Device Class
Class II
Regulation
21 CFR Part 866.3130
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent