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FDA 510(k)

BILE ACIDS REAGENT

K-Number: K872296 · 1987-08-26

ApplicantSigma Diagnostics, Inc.
Decision Date1987-08-26
Product CodeKWW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILE ACIDS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-08-26 under 510(k) number K872296. 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 BILE ACIDS REAGENT?

BILE ACIDS REAGENT is a medical device that received FDA 510(k) clearance on 1987-08-26. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K872296.

When did BILE ACIDS REAGENT receive FDA 510(k) clearance?

BILE ACIDS REAGENT received FDA 510(k) clearance on 1987-08-26, under 510(k) number K872296.

Who is the listed applicant for BILE ACIDS REAGENT?

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

What is the FDA product code for BILE ACIDS REAGENT?

The FDA product code for BILE ACIDS REAGENT is KWW.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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.K051714TOTAL BILE ACIDS ASSAY, MODEL DZ042ADiazyme LaboratoriesK970120BILE ACIDS REAGENT SETTeco DiagnosticsK803296ENDAB 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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