Advia Centaur Calibrator 30, Models 10379811/10379810

FDA 510(k) K100293 · Siemens Heatlhcare Diagnostics, Inc.

Substantially Equivalent

510(k) numberK100293

Submission

Device name
Advia Centaur Calibrator 30, Models 10379811/10379810
Applicant
Siemens Heatlhcare Diagnostics, Inc.
Tarrytown, NY, US
Received
February 2, 2010
Decision date
March 19, 2010
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIT – Calibrator, Secondary
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

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Questions and answers

When was Advia Centaur Calibrator 30, Models 10379811/10379810 cleared by the FDA?

Advia Centaur Calibrator 30, Models 10379811/10379810 (K100293) received a 510(k) decision of Substantially Equivalent on March 19, 2010, 45 days after the submission was received.

What is the product code of K100293?

The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.