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FDA 510(k)

CREATININE REAGENT SET

K-Number: K844024 · 1984-10-30

ApplicantLivonia Diagnostics, Inc.
Decision Date1984-10-30
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Livonia Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-10-30 under 510(k) number K844024. 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?

CREATININE REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-10-30. The listed applicant is Livonia Diagnostics, Inc.. The 510(k) number is K844024.

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

CREATININE REAGENT SET received FDA 510(k) clearance on 1984-10-30, under 510(k) number K844024.

Who is the listed applicant for CREATININE REAGENT SET?

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

What is the FDA product code for CREATININE REAGENT SET?

The FDA product code for CREATININE REAGENT SET is CGX.

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Other records listing Livonia 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.

K852161SERUM IRON/VIBC REAGENT SETK844322SGOT REAGENT SETK844283SGPT REAGENT SETK844237ALKALINE PHOSPHATASE REAGENT SETK844156UREA NITROGEN REAGENT SETK844182INORGANIC PHOSPHORUS REAGENT SET

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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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