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FDA 510(k)

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

K-Number: K023407 · 2003-02-14

ApplicantElan Diagnostics
Decision Date2003-02-14
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2003-02-14 under 510(k) number K023407. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR?

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR is a medical device that received FDA 510(k) clearance on 2003-02-14. The listed applicant is Elan Diagnostics. The 510(k) number is K023407.

When did ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR receive FDA 510(k) clearance?

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR received FDA 510(k) clearance on 2003-02-14, under 510(k) number K023407.

Who is the listed applicant for ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR?

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

What is the FDA product code for ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR?

The FDA product code for ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR is CGX.

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Other records listing Elan 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.

K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030014ATAC TOTAL BILIRUBIN REAGENTK030621ATAC CALIBRATORK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030010ATAC PAK MAGNESIUM REAGENTK030015ATAC PAK PHOSPHORUS REAGENT

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Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc.

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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