ENA-C-T TOTAL CHOLESTEROL TEST


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K960377
Device Name ENA-C-T TOTAL CHOLESTEROL TEST
Applicant
ACTIMED LABORATORIES, INC.
5 terri ln.
burlington, 
NJ 
08016

Applicant Contact susan mcgeehan
Correspondent
ACTIMED LABORATORIES, INC.
5 terri ln.
burlington, 
NJ 
08016

Correspodent Contact susan mcgeehan
Regulation Number 862.1175
Classification Product Code
CHH  
Date Received 01/26/1996
Decision Date 05/02/1996
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