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FDA 510(k)

DIAZYME SODIUM ENZYMATIC ASSAY

K-Number: K042189 · 2004-10-07

ApplicantDiazyme Laboratories
Decision Date2004-10-07
Product CodeMZU
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME SODIUM ENZYMATIC 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 2004-10-07 under 510(k) number K042189. 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 SODIUM ENZYMATIC ASSAY?

DIAZYME SODIUM ENZYMATIC ASSAY is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Diazyme Laboratories. The 510(k) number is K042189.

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

DIAZYME SODIUM ENZYMATIC ASSAY received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042189.

Who is the listed applicant for DIAZYME SODIUM ENZYMATIC 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 SODIUM ENZYMATIC ASSAY?

The FDA product code for DIAZYME SODIUM ENZYMATIC ASSAY is MZU.

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Other records listing Diazyme Laboratories as applicant

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K172992Diazyme EZ Vitamin D AssayK163418Diazyme DZ-Lite Total beta-hCG Test SystemK162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetK160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetK153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorK161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

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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.

K082763DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114BDiazyme 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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