ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K960378
Device Name ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
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 862.1660
Classification Product Code
JJX  
Date Received 01/26/1996
Decision Date 04/03/1996
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