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FDA 510(k)

ADVIA CHEMISTRY ENZYMATIC CREATININE_2

K-Number: K070727 · 2007-08-03

ApplicantSiemens Medical Solutions Diagnostics
Decision Date2007-08-03
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY ENZYMATIC CREATININE_2 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Diagnostics. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K070727. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CHEMISTRY ENZYMATIC CREATININE_2?

ADVIA CHEMISTRY ENZYMATIC CREATININE_2 is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Siemens Medical Solutions Diagnostics. The 510(k) number is K070727.

When did ADVIA CHEMISTRY ENZYMATIC CREATININE_2 receive FDA 510(k) clearance?

ADVIA CHEMISTRY ENZYMATIC CREATININE_2 received FDA 510(k) clearance on 2007-08-03, under 510(k) number K070727.

Who is the listed applicant for ADVIA CHEMISTRY ENZYMATIC CREATININE_2?

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

What is the FDA product code for ADVIA CHEMISTRY ENZYMATIC CREATININE_2?

The FDA product code for ADVIA CHEMISTRY ENZYMATIC CREATININE_2 is JFY.

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Other records listing Siemens Medical Solutions Diagnostics as applicant

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Related Devices (Code: JFY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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