CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3


Device Classification Name

enzyme controls (assayed and unassayed)

510(k) Number K992430
Device Name CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
542 flynn rd.
camarillo, 
CA 
93012 -8058

Applicant Contact scot d kinghorn
Correspondent
MEDICAL ANALYSIS SYSTEMS, INC.
542 flynn rd.
camarillo, 
CA 
93012 -8058

Correspodent Contact scot d kinghorn
Regulation Number 862.1660
Classification Product Code
JJT  
Date Received 07/21/1999
Decision Date 08/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Toxicology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No