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Sta R Max

by Diagnostica Stago S.A.S

510(k) K151867

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Special NumberK151867 Date7 Aug 2015ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1575-2023 FDA Class II initiated 22 Mar 2023

    An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

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  • Withdrawn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
JPA
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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