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FDA 510(k)

SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT

K-Number: K972743 · 1997-09-22

ApplicantSigma Diagnostics, Inc.
Decision Date1997-09-22
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT 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 1997-09-22 under 510(k) number K972743. 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, SIGMA DIAGNOSTICS CREATININE REAGENT?

SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT is a medical device that received FDA 510(k) clearance on 1997-09-22. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K972743.

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

SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT received FDA 510(k) clearance on 1997-09-22, under 510(k) number K972743.

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

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, SIGMA DIAGNOSTICS CREATININE REAGENT?

The FDA product code for SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT 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

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Related Devices (Code: CGX)

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Official Source

View on FDA Database →

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