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510(k) K063160

ALLERGEAZE PATCH TEST CHAMBERS by Smartpractice — Product Code KXF

K063160 is an FDA 510(k) premarket notification submitted by Smartpractice for the device "ALLERGEAZE PATCH TEST CHAMBERS". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. Smartpractice has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2006
Date Received
October 17, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type

Other clearances by Smartpractice

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • K103409 — ALLERGEAZE R CLEAR (March 15, 2011)
  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (December 11, 2002)

Other clearances for product code KXF

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • K103409 — ALLERGEAZE R CLEAR (March 15, 2011)
  • K013820 — FINN CHAMBER (R) (January 30, 2002)
  • K992553 — IQ CHAMBERS (April 12, 2000)
  • K870762 — EAR APPLICATOR, CATALOG NO. 2229 (March 6, 1987)
  • K843720 — COTTON TIPPED APPLICATORS, SINGLE (October 4, 1984)
  • K820962 — COTTON SWABS (April 20, 1982)
  • K813506 — FARRORS TMJ CASSETTE HOLDER (January 29, 1982)
  • K811365 — HILL TOP CHAMBER (August 20, 1981)
  • K802580 — SUBCLAVIAN CATHETER INSERTION TRAY (November 12, 1980)

FDA data resources