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FDA 510(k)

CREATININE REAGENT FOR DEMAND ANALYZER

K-Number: K844332 · 1985-01-03

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1985-01-03
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT FOR DEMAND ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1985-01-03 under 510(k) number K844332. 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 FOR DEMAND ANALYZER?

CREATININE REAGENT FOR DEMAND ANALYZER is a medical device that received FDA 510(k) clearance on 1985-01-03. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K844332.

When did CREATININE REAGENT FOR DEMAND ANALYZER receive FDA 510(k) clearance?

CREATININE REAGENT FOR DEMAND ANALYZER received FDA 510(k) clearance on 1985-01-03, under 510(k) number K844332.

Who is the listed applicant for CREATININE REAGENT FOR DEMAND ANALYZER?

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

What is the FDA product code for CREATININE REAGENT FOR DEMAND ANALYZER?

The FDA product code for CREATININE REAGENT FOR DEMAND ANALYZER is CGX.

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Other records listing Advanced Biomedical Methods, 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.

K945353CLARIT(TM)K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZERK864866RESUBMISSION OF THE KLEERZIT REAGENTK852784ALKALINE PHOSPHATASEK852783SGOT/ALT REAGENTK852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER

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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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