STA R MAX— 510(k) K151867

Name: FDA 510(k) clearance K151867
Creator: U.S. Food and Drug Administration
Published: 2015-08-07

Substantially Equivalent

Diagnostica Stago S.A.S

FDA 510(k) clearance K151867 for STA R MAX, Substantially Equivalent on 2015-08-07. Applicant: Diagnostica Stago S.A.S. Device class: 2.

Clearance details

Applicant: Diagnostica Stago S.A.S
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2015-07-09
Decision date: 2015-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Gennevilliers, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K151867

K-number listed on FDA's recall record

Z-1575-2023 — STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026Class II·Ongoing·Diagnostica Stago, Inc.·20230322

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151867.

Data sourced from openFDA. This site is unofficial and independent of the FDA.