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FDA 510(k)

TOTAL BILE ACIDS ASSAY, MODEL DZ042A

K-Number: K051714 · 2005-12-07

ApplicantDiazyme Laboratories
Decision Date2005-12-07
Product CodeKWW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL BILE ACIDS ASSAY, MODEL DZ042A is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K051714. The device is classified under product code KWW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL BILE ACIDS ASSAY, MODEL DZ042A?

TOTAL BILE ACIDS ASSAY, MODEL DZ042A is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is Diazyme Laboratories. The 510(k) number is K051714.

When did TOTAL BILE ACIDS ASSAY, MODEL DZ042A receive FDA 510(k) clearance?

TOTAL BILE ACIDS ASSAY, MODEL DZ042A received FDA 510(k) clearance on 2005-12-07, under 510(k) number K051714.

Who is the listed applicant for TOTAL BILE ACIDS ASSAY, MODEL DZ042A?

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 TOTAL BILE ACIDS ASSAY, MODEL DZ042A?

The FDA product code for TOTAL BILE ACIDS ASSAY, MODEL DZ042A is KWW.

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Related Devices (Code: KWW)

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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITCatachem, Inc.K970120BILE ACIDS REAGENT SETTeco DiagnosticsK872296BILE ACIDS REAGENTSigma Diagnostics, Inc.K803296ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KITImmunotech Corp.K781337CONJUGATED BILE ACIDS RIA KITBd Becton Dickinson Vacutainer Systems Preanalytic

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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