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FDA 510(k)

DIAZYME POTASSIUM ENZYMATIC ASSAY KIT

K-Number: K042191 · 2004-10-29

ApplicantDiazyme Laboratories
Decision Date2004-10-29
Product CodeMZV
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME POTASSIUM ENZYMATIC ASSAY 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 2004-10-29 under 510(k) number K042191. The device is classified under product code MZV. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME POTASSIUM ENZYMATIC ASSAY KIT?

DIAZYME POTASSIUM ENZYMATIC ASSAY KIT is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Diazyme Laboratories. The 510(k) number is K042191.

When did DIAZYME POTASSIUM ENZYMATIC ASSAY KIT receive FDA 510(k) clearance?

DIAZYME POTASSIUM ENZYMATIC ASSAY KIT received FDA 510(k) clearance on 2004-10-29, under 510(k) number K042191.

Who is the listed applicant for DIAZYME POTASSIUM ENZYMATIC ASSAY 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 POTASSIUM ENZYMATIC ASSAY KIT?

The FDA product code for DIAZYME POTASSIUM ENZYMATIC ASSAY KIT is MZV.

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Related Devices (Code: MZV)

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.

K200865Piccolo Potassium Test SystemAbaxis, Inc.K091455DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CALDiazyme LaboratoriesK053566MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113ADiazyme Laboratories

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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