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FDA 510(k)

ENZYMATIC CREATININE ASSAY (265 SERIES)

K-Number: K070383 · 2007-06-22

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2007-06-22
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CREATININE ASSAY (265 SERIES) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K070383. 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 ENZYMATIC CREATININE ASSAY (265 SERIES)?

ENZYMATIC CREATININE ASSAY (265 SERIES) is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K070383.

When did ENZYMATIC CREATININE ASSAY (265 SERIES) receive FDA 510(k) clearance?

ENZYMATIC CREATININE ASSAY (265 SERIES) received FDA 510(k) clearance on 2007-06-22, under 510(k) number K070383.

Who is the listed applicant for ENZYMATIC CREATININE ASSAY (265 SERIES)?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYMATIC CREATININE ASSAY (265 SERIES)?

The FDA product code for ENZYMATIC CREATININE ASSAY (265 SERIES) is 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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