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FDA 510(k)

URINARY/CEREBROSPINAL FLUID PROTEIN

K-Number: K934841 · 1994-04-06

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1994-04-06
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINARY/CEREBROSPINAL FLUID PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K934841. 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 URINARY/CEREBROSPINAL FLUID PROTEIN?

URINARY/CEREBROSPINAL FLUID PROTEIN is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K934841.

When did URINARY/CEREBROSPINAL FLUID PROTEIN receive FDA 510(k) clearance?

URINARY/CEREBROSPINAL FLUID PROTEIN received FDA 510(k) clearance on 1994-04-06, under 510(k) number K934841.

Who is the listed applicant for URINARY/CEREBROSPINAL FLUID PROTEIN?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINARY/CEREBROSPINAL FLUID PROTEIN?

The FDA product code for URINARY/CEREBROSPINAL FLUID PROTEIN is CEK.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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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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