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FDA 510(k)

SYNERMED CREATININE REAGENT KIT

K-Number: K974909 · 1998-02-24

ApplicantSynermed Intl., Inc.
Decision Date1998-02-24
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED CREATININE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed Intl., Inc.. It received FDA 510(k) clearance on 1998-02-24 under 510(k) number K974909. 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 SYNERMED CREATININE REAGENT KIT?

SYNERMED CREATININE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Synermed Intl., Inc.. The 510(k) number is K974909.

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

SYNERMED CREATININE REAGENT KIT received FDA 510(k) clearance on 1998-02-24, under 510(k) number K974909.

Who is the listed applicant for SYNERMED CREATININE REAGENT KIT?

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

What is the FDA product code for SYNERMED CREATININE REAGENT KIT?

The FDA product code for SYNERMED CREATININE REAGENT KIT is CGX.

Related Clinical Trials

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Other records listing Synermed Intl., 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.

K983304SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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