QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K023731
Device Name QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
Original Applicant
CONSOLIDATED TECHNOLOGY
4401 freidrich ln. bldg 1
suite 100
austin, 
TX 
78744 -1832

Original Contact candice betz
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 11/06/2002
Decision Date 12/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No