THE HELENA V8 IMMUNODISPLACEMENT KIT


Device Classification Name

immunoelectrophoretic, immunoglobulins, (g, a, m)

510(k) Number K111369
Device Name THE HELENA V8 IMMUNODISPLACEMENT KIT
Applicant
HELENA LABORATORIES UK LTD
po box 752, 1530 lindebergh
drive
beaumont, 
TX 
77704 -0752

Applicant Contact patricia franks
Correspondent
HELENA LABORATORIES UK LTD
po box 752, 1530 lindebergh
drive
beaumont, 
TX 
77704 -0752

Correspodent Contact patricia franks
Regulation Number 866.5510
Classification Product Code
CFF  
Date Received 05/16/2011
Decision Date 06/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No