WAKO AUTOKIT C4


Device Classification Name

complement c4, antigen, antiserum, control

510(k) Number K010325
Device Name WAKO AUTOKIT C4
Original Applicant
WAKO CHEMICALS, USA, INC.
1600 bellwood road
richmond, 
VA 
23237

Original Contact tonya mallory
Regulation Number 866.5240
Classification Product Code
DBI  
Subsequent Product Code
JIX  
Date Received 02/02/2001
Decision Date 06/25/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No