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FDA 510(k)

CSF/URINE TOTAL PROTEIN

K-Number: K961864 · 1996-10-24

ApplicantTeco Diagnostics
Decision Date1996-10-24
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CSF/URINE TOTAL PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1996-10-24 under 510(k) number K961864. 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 CSF/URINE TOTAL PROTEIN?

CSF/URINE TOTAL PROTEIN is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Teco Diagnostics. The 510(k) number is K961864.

When did CSF/URINE TOTAL PROTEIN receive FDA 510(k) clearance?

CSF/URINE TOTAL PROTEIN received FDA 510(k) clearance on 1996-10-24, under 510(k) number K961864.

Who is the listed applicant for CSF/URINE TOTAL PROTEIN?

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

What is the FDA product code for CSF/URINE TOTAL PROTEIN?

The FDA product code for CSF/URINE TOTAL PROTEIN is CEK.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

View all 49 devices →

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.K955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.K955936TOTAL PROTEIN REAGENTDerma Media Lab., 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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