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FDA 510(k)

QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT

K-Number: K853930 · 1985-12-10

ApplicantQuantimetrix Corp.
Decision Date1985-12-10
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 1985-12-10 under 510(k) number K853930. 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 QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT?

QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-12-10. The listed applicant is Quantimetrix Corp.. The 510(k) number is K853930.

When did QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT receive FDA 510(k) clearance?

QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT received FDA 510(k) clearance on 1985-12-10, under 510(k) number K853930.

Who is the listed applicant for QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT?

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

What is the FDA product code for QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT?

The FDA product code for QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT is CEK.

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Other records listing Quantimetrix Corp. 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.

K113177COMPLETE D 25-OH VITAMIN D CONTROLK103744DROPPER A1C DIABETES CONTROLK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLK062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROL

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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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