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FDA 510(k)

DIAZYME CYSTATIN C POC TEST KIT

K-Number: K111664 · 2012-03-30

ApplicantDiazyme Laboratories
Decision Date2012-03-30
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME CYSTATIN C POC TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2012-03-30 under 510(k) number K111664. 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 POC TEST KIT?

DIAZYME CYSTATIN C POC TEST KIT is a medical device that received FDA 510(k) clearance on 2012-03-30. The listed applicant is Diazyme Laboratories. The 510(k) number is K111664.

When did DIAZYME CYSTATIN C POC TEST KIT receive FDA 510(k) clearance?

DIAZYME CYSTATIN C POC TEST KIT received FDA 510(k) clearance on 2012-03-30, under 510(k) number K111664.

Who is the listed applicant for DIAZYME CYSTATIN C POC TEST KIT?

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 POC TEST KIT?

The FDA product code for DIAZYME CYSTATIN C POC TEST KIT 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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