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FDA 510(k)

SIGMA 610 FOR PROTEIN IN URINE & CSF

K-Number: K853681 · 1985-10-28

ApplicantSigma Diagnostics, Inc.
Decision Date1985-10-28
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA 610 FOR PROTEIN IN URINE & CSF 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 1985-10-28 under 510(k) number K853681. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA 610 FOR PROTEIN IN URINE & CSF?

SIGMA 610 FOR PROTEIN IN URINE & CSF is a medical device that received FDA 510(k) clearance on 1985-10-28. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K853681.

When did SIGMA 610 FOR PROTEIN IN URINE & CSF receive FDA 510(k) clearance?

SIGMA 610 FOR PROTEIN IN URINE & CSF received FDA 510(k) clearance on 1985-10-28, under 510(k) number K853681.

Who is the listed applicant for SIGMA 610 FOR PROTEIN IN URINE & CSF?

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 610 FOR PROTEIN IN URINE & CSF?

The FDA product code for SIGMA 610 FOR PROTEIN IN URINE & CSF is CEK.

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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 A7971K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,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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