MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K023669
Device Name MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA
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 10/31/2002
Decision Date 12/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No