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FDA 510(k)

BILE ACIDS REAGENT SET

K-Number: K970120 · 1997-03-24

ApplicantTeco Diagnostics
Decision Date1997-03-24
Product CodeKWW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILE ACIDS REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1997-03-24 under 510(k) number K970120. 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 SET?

BILE ACIDS REAGENT SET is a medical device that received FDA 510(k) clearance on 1997-03-24. The listed applicant is Teco Diagnostics. The 510(k) number is K970120.

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

BILE ACIDS REAGENT SET received FDA 510(k) clearance on 1997-03-24, under 510(k) number K970120.

Who is the listed applicant for BILE ACIDS REAGENT SET?

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

What is the FDA product code for BILE ACIDS REAGENT SET?

The FDA product code for BILE ACIDS REAGENT SET is KWW.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

View all 49 devices →

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 LaboratoriesK872296BILE 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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