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FDA 510(k)

URINE/CSF MICROPROTEIN REAGENT

K-Number: K913225 · 1991-10-11

ApplicantIntersect Systems, Inc.
Decision Date1991-10-11
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE/CSF MICROPROTEIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K913225. 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 URINE/CSF MICROPROTEIN REAGENT?

URINE/CSF MICROPROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K913225.

When did URINE/CSF MICROPROTEIN REAGENT receive FDA 510(k) clearance?

URINE/CSF MICROPROTEIN REAGENT received FDA 510(k) clearance on 1991-10-11, under 510(k) number K913225.

Who is the listed applicant for URINE/CSF MICROPROTEIN REAGENT?

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

What is the FDA product code for URINE/CSF MICROPROTEIN REAGENT?

The FDA product code for URINE/CSF MICROPROTEIN REAGENT is CEK.

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Other records listing Intersect Systems, 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.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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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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