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FDA 510(k)

QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM

K-Number: K904603 · 1991-01-25

ApplicantQuantitative Medicine, Inc.
Decision Date1991-01-25
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quantitative Medicine, Inc.. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K904603. 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 QUAN TEST-RED PROTEIN ASSAY SYSTEM?

QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Quantitative Medicine, Inc.. The 510(k) number is K904603.

When did QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM receive FDA 510(k) clearance?

QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM received FDA 510(k) clearance on 1991-01-25, under 510(k) number K904603.

Who is the listed applicant for QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM?

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

What is the FDA product code for QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM?

The FDA product code for QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM is CEK.

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Other records listing Quantitative Medicine, 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.

K963608QUANTITATIVE SENTINEL SYSTEMK960109QUANTITATIVE SENTINEL SYSTEMK923255Q-SDK912462Q-MS NEUROMUSCULAR STIMULATORK912460Q-TENSK912463MICRO-Q

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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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