DeviceClearance

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material— 510(k) K152061

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K152061 for IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material, Substantially Equivalent on 2016-03-03. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code JZO
Device class
Class 2
Regulation
21 CFR 866.5870
Advisory panel
Immunology
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 JZO

view all

More clearances from Siemens Healthcare Diagnostics, Inc.

view all

Recalls naming K152061

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152061.

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