ELITECH CLINICAL SYSTEMS CK NAC SL


Device Classification Name

u.v. method, cpk isoenzymes

510(k) Number K122083
Device Name ELITECH CLINICAL SYSTEMS CK NAC SL
Applicant
ELITECHGROUP
21720 23rd dr se
suite 150
bothell, 
WA 
98021

Applicant Contact debra k hutson
Correspondent
ELITECHGROUP
21720 23rd dr se
suite 150
bothell, 
WA 
98021

Correspodent Contact debra k hutson
Regulation Number 862.1215
Classification Product Code
JHW  
Subsequent Product Codes
JIX   JJY  
Date Received 07/16/2012
Decision Date 08/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No