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FDA 510(k)

ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810

K-Number: K100293 · 2010-03-19

ApplicantSiemens Heatlhcare Diagnostics, Inc.
Decision Date2010-03-19
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Heatlhcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2010-03-19 under 510(k) number K100293. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810?

ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 is a medical device that received FDA 510(k) clearance on 2010-03-19. The listed applicant is Siemens Heatlhcare Diagnostics, Inc.. The 510(k) number is K100293.

When did ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 receive FDA 510(k) clearance?

ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 received FDA 510(k) clearance on 2010-03-19, under 510(k) number K100293.

Who is the listed applicant for ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810?

The FDA 510(k) record lists Siemens Heatlhcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810?

The FDA product code for ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 is JIT.

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Official Source

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