DeviceClearance

IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material— 510(k) K143352

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K143352 for IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material, Substantially Equivalent on 2014-12-24. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Tarrytown, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JJX

product code JJX
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.