MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K023867
Device Name MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
Original Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
5300 adolfo rd.
camarillo, 
CA 
93012

Original Contact penny m layman
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 11/20/2002
Decision Date 12/17/2002
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