ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810— 510(k) K100293

Name: FDA 510(k) clearance K100293
Creator: U.S. Food and Drug Administration
Published: 2010-03-19

Substantially Equivalent

Siemens Heatlhcare Diagnostics, Inc.

FDA 510(k) clearance K100293 for ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810, Substantially Equivalent on 2010-03-19. Applicant: Siemens Heatlhcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Heatlhcare Diagnostics, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2010-02-02
Decision date: 2010-03-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K100293

K-number listed on FDA's recall record

Z-0515-2018 — ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20170607

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100293.

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