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FDA 510(k)

ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL

K-Number: K092993 · 2009-11-20

ApplicantSiemens Healthcare Diagnostics
Decision Date2009-11-20
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL 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 2009-11-20 under 510(k) number K092993. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL?

ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K092993.

When did ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL receive FDA 510(k) clearance?

ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL received FDA 510(k) clearance on 2009-11-20, under 510(k) number K092993.

Who is the listed applicant for ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL?

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 CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL?

The FDA product code for ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL is JJX.

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Official Source

View on FDA Database →

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

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