POLYSLIT IFE KIT


Device Classification Name

immunoelectrophoretic, immunoglobulins, (g, a, m)

510(k) Number K990998
Device Name POLYSLIT IFE KIT
Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Applicant Contact pat franks
Correspondent
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Correspodent Contact pat franks
Regulation Number 866.5510
Classification Product Code
CFF  
Date Received 03/25/1999
Decision Date 06/28/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No