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FDA 510(k)

DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B

K-Number: K082763 · 2008-11-12

ApplicantDiazyme Laboratories
Decision Date2008-11-12
Product CodeMZU
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2008-11-12 under 510(k) number K082763. The device is classified under product code MZU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B?

DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B is a medical device that received FDA 510(k) clearance on 2008-11-12. The listed applicant is Diazyme Laboratories. The 510(k) number is K082763.

When did DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B receive FDA 510(k) clearance?

DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B received FDA 510(k) clearance on 2008-11-12, under 510(k) number K082763.

Who is the listed applicant for DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B?

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 LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B?

The FDA product code for DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B is MZU.

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Related Devices (Code: MZU)

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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