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FDA 510(k)

PROTEIN TEST FOR URINE AND CSF

K-Number: K900733 · 1990-07-10

ApplicantElite Technology, Inc.
Decision Date1990-07-10
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROTEIN TEST FOR URINE AND CSF is the device name listed in this FDA 510(k) record. The listed applicant is Elite Technology, Inc.. It received FDA 510(k) clearance on 1990-07-10 under 510(k) number K900733. 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 PROTEIN TEST FOR URINE AND CSF?

PROTEIN TEST FOR URINE AND CSF is a medical device that received FDA 510(k) clearance on 1990-07-10. The listed applicant is Elite Technology, Inc.. The 510(k) number is K900733.

When did PROTEIN TEST FOR URINE AND CSF receive FDA 510(k) clearance?

PROTEIN TEST FOR URINE AND CSF received FDA 510(k) clearance on 1990-07-10, under 510(k) number K900733.

Who is the listed applicant for PROTEIN TEST FOR URINE AND CSF?

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

What is the FDA product code for PROTEIN TEST FOR URINE AND CSF?

The FDA product code for PROTEIN TEST FOR URINE AND CSF is CEK.

Related Clinical Trials

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Other records listing Elite Technology, 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.

K901001URIC ACID TEST KITK901090ELITECH GAMMA GT TEST KITK895951CHOLESTEROL TEST KITK895952TRIGLYCERIDES TEST KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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