HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K011169
Device Name HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
Original Applicant
INTERNATIONAL ENZYMES, INC.
1432-b south mission rd.
fallbrook, 
CA 
92028

Original Contact carol ruggiero
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 04/17/2001
Decision Date 05/18/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No