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FDA 510(k)

SIGMA DIAGNOSTICS CREATININE REAGENT KIT

K-Number: K963534 · 1996-09-30

ApplicantSigma Diagnostics, Inc.
Decision Date1996-09-30
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS CREATININE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-09-30 under 510(k) number K963534. 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 SIGMA DIAGNOSTICS CREATININE REAGENT KIT?

SIGMA DIAGNOSTICS CREATININE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1996-09-30. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K963534.

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

SIGMA DIAGNOSTICS CREATININE REAGENT KIT received FDA 510(k) clearance on 1996-09-30, under 510(k) number K963534.

Who is the listed applicant for SIGMA DIAGNOSTICS CREATININE REAGENT KIT?

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

What is the FDA product code for SIGMA DIAGNOSTICS CREATININE REAGENT KIT?

The FDA product code for SIGMA DIAGNOSTICS CREATININE REAGENT KIT is CGX.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

View all 164 devices →

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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