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FDA 510(k)

ADVIA CHEMISTRY GLUH_3 REAGENTS

K-Number: K120681 · 2012-05-15

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2012-05-15
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY GLUH_3 REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-05-15 under 510(k) number K120681. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CHEMISTRY GLUH_3 REAGENTS?

ADVIA CHEMISTRY GLUH_3 REAGENTS is a medical device that received FDA 510(k) clearance on 2012-05-15. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K120681.

When did ADVIA CHEMISTRY GLUH_3 REAGENTS receive FDA 510(k) clearance?

ADVIA CHEMISTRY GLUH_3 REAGENTS received FDA 510(k) clearance on 2012-05-15, under 510(k) number K120681.

Who is the listed applicant for ADVIA CHEMISTRY GLUH_3 REAGENTS?

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

What is the FDA product code for ADVIA CHEMISTRY GLUH_3 REAGENTS?

The FDA product code for ADVIA CHEMISTRY GLUH_3 REAGENTS is CFR.

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Official Source

View on FDA Database →

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