IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL— 510(k) K131662

Name: FDA 510(k) clearance K131662
Creator: U.S. Food and Drug Administration
Published: 2013-10-10

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K131662 for IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL, Substantially Equivalent on 2013-10-10. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JJX
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2013-06-07
Decision date: 2013-10-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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 →

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