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FDA 510(k)

CREATININE REAGENT SET (KINETIC)

K-Number: K880843 · 1988-04-05

ApplicantTech-Neal Scientific, Inc.
Decision Date1988-04-05
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT SET (KINETIC) is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Neal Scientific, Inc.. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K880843. 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 CREATININE REAGENT SET (KINETIC)?

CREATININE REAGENT SET (KINETIC) is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Tech-Neal Scientific, Inc.. The 510(k) number is K880843.

When did CREATININE REAGENT SET (KINETIC) receive FDA 510(k) clearance?

CREATININE REAGENT SET (KINETIC) received FDA 510(k) clearance on 1988-04-05, under 510(k) number K880843.

Who is the listed applicant for CREATININE REAGENT SET (KINETIC)?

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

What is the FDA product code for CREATININE REAGENT SET (KINETIC)?

The FDA product code for CREATININE REAGENT SET (KINETIC) is CGX.

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Other records listing Tech-Neal Scientific, 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.

K882256MAGNESIUM REAGENT SETK882459DIAZO, COLORIMETRIC BILIRUBINK881239GAMMA GLUTAMYL TRANSFERASE REAGENT SETK881241TOTAL BILIRUBIN REAGENTK881240CHLORIDE REAGENT SETK880237CHOLESTEROL

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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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