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FDA 510(k)

RAICHEM CREATININE REAGENT

K-Number: K840872 · 1984-04-18

ApplicantReagents Applications, Inc.
Decision Date1984-04-18
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM CREATININE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1984-04-18 under 510(k) number K840872. 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 RAICHEM CREATININE REAGENT?

RAICHEM CREATININE REAGENT is a medical device that received FDA 510(k) clearance on 1984-04-18. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K840872.

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

RAICHEM CREATININE REAGENT received FDA 510(k) clearance on 1984-04-18, under 510(k) number K840872.

Who is the listed applicant for RAICHEM CREATININE REAGENT?

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

What is the FDA product code for RAICHEM CREATININE REAGENT?

The FDA product code for RAICHEM CREATININE REAGENT is CGX.

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Other records listing Reagents Applications, Inc. as applicant

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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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