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510(k) K945519

FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM by Pharmaquest Corp. — Product Code MPG

K945519 is an FDA 510(k) premarket notification submitted by Pharmaquest Corp. for the device "FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on November 3, 1995. The device falls under product code MPG (Urinary Carbohydrate Analysis Kit), a Class I device regulated under 21 CFR 862.1505. Pharmaquest Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1995
Date Received
November 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Carbohydrate Analysis Kit
Device Class
Class I
Regulation Number
862.1505
Review Panel
CH
Submission Type

Other clearances by Pharmaquest Corp.

  • K833236 — TELEPHONE TRANSMITTER T-10 EEG (November 29, 1983)
  • K833880 — TELEPHONIC RECEIVER R-10 EEG (November 29, 1983)
  • K830705 — MINI LANCET-BLOOD LANCET (April 8, 1983)
  • K822976 — HYPOCOUNT A (November 16, 1982)
  • K822486 — HOME BLOOD GLUCOSE MONITOR (November 5, 1982)
  • K820248 — RODDER VOLUME VENTILATOR (April 16, 1982)
  • K812850 — PTT-200 PULMONARY RECEIVER/MICROPROCES (December 3, 1981)
  • K812849 — PTT-200 TELEPHONIC PULMONARY TRANSMITT (December 3, 1981)
  • K813010 — EEG TELEPHONE TRANSMITTER, MODEL #T-7 (November 16, 1981)
  • K812683 — NEONATE FLEXFLOAT (October 13, 1981)

FDA data resources