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FDA 510(k)

DIAZYME CREATININE LIQUID REAGENTS ASSAY

K-Number: K062105 · 2007-04-23

ApplicantDiazyme Laboratories
Decision Date2007-04-23
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME CREATININE LIQUID REAGENTS ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2007-04-23 under 510(k) number K062105. 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 DIAZYME CREATININE LIQUID REAGENTS ASSAY?

DIAZYME CREATININE LIQUID REAGENTS ASSAY is a medical device that received FDA 510(k) clearance on 2007-04-23. The listed applicant is Diazyme Laboratories. The 510(k) number is K062105.

When did DIAZYME CREATININE LIQUID REAGENTS ASSAY receive FDA 510(k) clearance?

DIAZYME CREATININE LIQUID REAGENTS ASSAY received FDA 510(k) clearance on 2007-04-23, under 510(k) number K062105.

Who is the listed applicant for DIAZYME CREATININE LIQUID REAGENTS ASSAY?

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

What is the FDA product code for DIAZYME CREATININE LIQUID REAGENTS ASSAY?

The FDA product code for DIAZYME CREATININE LIQUID REAGENTS ASSAY is JFY.

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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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