FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM— 510(k) K945519

Name: FDA 510(k) clearance K945519
Creator: U.S. Food and Drug Administration
Published: 1995-11-03

Substantially Equivalent

Pharmaquest Corp.

FDA 510(k) clearance K945519 for FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM, Substantially Equivalent on 1995-11-03. Applicant: Pharmaquest Corp.. Device class: 1.

Clearance details

Applicant: Pharmaquest Corp.
Product code: Code MPG
Device class: Class 1
Regulation: 21 CFR 862.1505
Advisory panel: Clinical Chemistry
Date received: 1994-11-09
Decision date: 1995-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Rafael, CA, US

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