DeviceClearance

ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material— 510(k) K143687

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K143687 for ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material, Substantially Equivalent on 2015-07-17. 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
Traditional
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.