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FDA 510(k)

FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM

K-Number: K945519 · 1995-11-03

ApplicantPharmaquest Corp.
Decision Date1995-11-03
Product CodeMPG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaquest Corp.. It received FDA 510(k) clearance on 1995-11-03 under 510(k) number K945519. The device is classified under product code MPG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM?

FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-03. The listed applicant is Pharmaquest Corp.. The 510(k) number is K945519.

When did FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM receive FDA 510(k) clearance?

FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM received FDA 510(k) clearance on 1995-11-03, under 510(k) number K945519.

Who is the listed applicant for FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM?

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

What is the FDA product code for FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM?

The FDA product code for FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM is MPG.

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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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