510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945519Substantially Equivalent

Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis System

Pharmaquest Corp., San Rafael CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945519 is the FDA 510(k) clearance record for FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM, a class I device, cleared for Pharmaquest Corp. on under FDA product code MPG (Urinary Carbohydrate Analysis Kit). FDA records list 14 510(k) clearances for Pharmaquest Corp., from to . As of , FDA records show no recalls naming K945519.

Clearance record

Decision date
Received
(359 days to decision)
Product code
MPG Urinary Carbohydrate Analysis Kit
Regulation
21 CFR 862.1505
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Pharmaquest Corp. 4470 Redwood High Way, San Rafael CA
510(k) summary
Statement
Third party review
No

Clearances, product code MPG

Trailing 12 months

FDA records hold no clearances under product code MPG in the trailing twelve months.

FDA records show no clearances under product code MPG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MPG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260