SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389


Device Classification Name

immunoelectrophoretic, immunoglobulins, (g, a, m)

510(k) Number K024162
Device Name SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
Original Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Original Contact eric petersen
Regulation Number 866.5510
Classification Product Code
CFF  
Date Received 12/17/2002
Decision Date 02/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No