DeviceClearance

IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)— 510(k) K142811

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K142811 for IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM), Substantially Equivalent on 2014-10-29. 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 ↗

Recent devices under product code JJX

view all

More clearances from Siemens Healthcare Diagnostics, Inc.

view all

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.