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FDA 510(k)

GENCHEM CREATININE REAGENT

K-Number: K040976 · 2004-12-27

ApplicantGenchem, Inc.
Decision Date2004-12-27
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENCHEM CREATININE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Genchem, Inc.. It received FDA 510(k) clearance on 2004-12-27 under 510(k) number K040976. 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 GENCHEM CREATININE REAGENT?

GENCHEM CREATININE REAGENT is a medical device that received FDA 510(k) clearance on 2004-12-27. The listed applicant is Genchem, Inc.. The 510(k) number is K040976.

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

GENCHEM CREATININE REAGENT received FDA 510(k) clearance on 2004-12-27, under 510(k) number K040976.

Who is the listed applicant for GENCHEM CREATININE REAGENT?

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

What is the FDA product code for GENCHEM CREATININE REAGENT?

The FDA product code for GENCHEM CREATININE REAGENT is CGX.

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Other records listing Genchem, 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.

K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3K040975GENCHEM CO2 ACID REAGENTK040974GLUCOSE OXIDASE, GLUCOSEK040977GENCHEM ELECTROLYTE BUFFERK040972CALCIUM, AZO DYE REAGENTK040973BUN 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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