Home / 510(k) Clearances / K945519

510(k) K945519

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

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.

  • K833880 — TELEPHONIC RECEIVER R-10 EEG (November 29, 1983)
  • K833236 — TELEPHONE TRANSMITTER T-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)
  • K812849 — PTT-200 TELEPHONIC PULMONARY TRANSMITT (December 3, 1981)
  • K812850 — PTT-200 PULMONARY RECEIVER/MICROPROCES (December 3, 1981)
  • K813010 — EEG TELEPHONE TRANSMITTER, MODEL #T-7 (November 16, 1981)
  • K812683 — NEONATE FLEXFLOAT (October 13, 1981)