TOUCH TEAR IGE MICROASSAY KIT


Device Classification Name

ige, antigen, antiserum, control

510(k) Number K991316
Device Name TOUCH TEAR IGE MICROASSAY KIT
Applicant
TOUCH SCIENTIFIC, INC.
3209 gresham lake rd.
suite 112
raleigh, 
NC 
27615

Applicant Contact alan j touch
Correspondent
TOUCH SCIENTIFIC, INC.
3209 gresham lake rd.
suite 112
raleigh, 
NC 
27615

Correspodent Contact alan j touch
Regulation Number 866.5510
Classification Product Code
DGC  
Date Received 04/19/1999
Decision Date 08/09/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No