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FDA 510(k)

SYNERMED SINGLE REAGENT CREATININE KIT

K-Number: K926511 · 1993-02-18

ApplicantSynermed, Inc.
Decision Date1993-02-18
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED SINGLE REAGENT CREATININE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1993-02-18 under 510(k) number K926511. 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 SINGLE REAGENT CREATININE KIT?

SYNERMED SINGLE REAGENT CREATININE KIT is a medical device that received FDA 510(k) clearance on 1993-02-18. The listed applicant is Synermed, Inc.. The 510(k) number is K926511.

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

SYNERMED SINGLE REAGENT CREATININE KIT received FDA 510(k) clearance on 1993-02-18, under 510(k) number K926511.

Who is the listed applicant for SYNERMED SINGLE REAGENT CREATININE KIT?

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

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

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

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT 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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