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FDA 510(k)

MULTIGENT CREATININE (ENZYMATIC) ASSAY

K-Number: K073634 · 2008-06-19

ApplicantSENTINEL CH. SpA
Decision Date2008-06-19
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTIGENT CREATININE (ENZYMATIC) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2008-06-19 under 510(k) number K073634. 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 MULTIGENT CREATININE (ENZYMATIC) ASSAY?

MULTIGENT CREATININE (ENZYMATIC) ASSAY is a medical device that received FDA 510(k) clearance on 2008-06-19. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K073634.

When did MULTIGENT CREATININE (ENZYMATIC) ASSAY receive FDA 510(k) clearance?

MULTIGENT CREATININE (ENZYMATIC) ASSAY received FDA 510(k) clearance on 2008-06-19, under 510(k) number K073634.

Who is the listed applicant for MULTIGENT CREATININE (ENZYMATIC) ASSAY?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIGENT CREATININE (ENZYMATIC) ASSAY?

The FDA product code for MULTIGENT CREATININE (ENZYMATIC) ASSAY is JFY.

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Related Devices (Code: JFY)

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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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