FDA 510(k)

ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771

K-Number: K090900 · 2009-06-01

Decision Date2009-06-01

Product CodeDKB

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-06-01 under 510(k) number K090900. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771?

ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 is a medical device that received FDA 510(k) clearance on 2009-06-01. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K090900.

When did ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 receive FDA 510(k) clearance?

ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 received FDA 510(k) clearance on 2009-06-01, under 510(k) number K090900.

Who is the listed applicant for ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771?

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

What is the FDA product code for ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771?

The FDA product code for ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 is DKB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.