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FDA 510(k)

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT

K-Number: K062503 · 2007-01-19

ApplicantCatachem, Inc.
Decision Date2007-01-19
Product CodeKWW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 2007-01-19 under 510(k) number K062503. 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 CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT?

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT is a medical device that received FDA 510(k) clearance on 2007-01-19. The listed applicant is Catachem, Inc.. The 510(k) number is K062503.

When did CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT receive FDA 510(k) clearance?

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT received FDA 510(k) clearance on 2007-01-19, under 510(k) number K062503.

Who is the listed applicant for CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT?

The FDA 510(k) record lists Catachem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT?

The FDA product code for CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT is KWW.

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Other records listing Catachem, Inc. as applicant

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.

K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATEDK895748BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS

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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.

K051714TOTAL BILE ACIDS ASSAY, MODEL DZ042ADiazyme LaboratoriesK970120BILE 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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