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FDA 510(k)

FERMCOTEST CREATININE TEST REAGENT

K-Number: K822118 · 1982-09-30

ApplicantFermco Biochemics, Inc.
Decision Date1982-09-30
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FERMCOTEST CREATININE TEST REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Fermco Biochemics, Inc.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822118. 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 FERMCOTEST CREATININE TEST REAGENT?

FERMCOTEST CREATININE TEST REAGENT is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Fermco Biochemics, Inc.. The 510(k) number is K822118.

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

FERMCOTEST CREATININE TEST REAGENT received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822118.

Who is the listed applicant for FERMCOTEST CREATININE TEST REAGENT?

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

What is the FDA product code for FERMCOTEST CREATININE TEST REAGENT?

The FDA product code for FERMCOTEST CREATININE TEST REAGENT is CGX.

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Other records listing Fermco Biochemics, 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.

K843832TRIGLYCERIDES REAGENT SYSTEMK823106RERMCO TEST CHLORIDE REAGENTK822117FERMCOTEST CO2 REAGNETK810567GERMCO TEST R GLUCOSE TEST KITK791066GLUCOSE GOD-PAP TRINDER METHOD TEST KITK791018FERMCOTEST R BUN RATE REAGENT TEST KIT

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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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