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FDA 510(k)

DIAZYME CYSTATIN C ASSAY

K-Number: K093680 · 2010-04-08

ApplicantDiazyme Laboratories
Decision Date2010-04-08
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME CYSTATIN C 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 2010-04-08 under 510(k) number K093680. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME CYSTATIN C ASSAY?

DIAZYME CYSTATIN C ASSAY is a medical device that received FDA 510(k) clearance on 2010-04-08. The listed applicant is Diazyme Laboratories. The 510(k) number is K093680.

When did DIAZYME CYSTATIN C ASSAY receive FDA 510(k) clearance?

DIAZYME CYSTATIN C ASSAY received FDA 510(k) clearance on 2010-04-08, under 510(k) number K093680.

Who is the listed applicant for DIAZYME CYSTATIN C 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 CYSTATIN C ASSAY?

The FDA product code for DIAZYME CYSTATIN C ASSAY is NDY.

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Related Devices (Code: NDY)

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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