K-ASSAY LP(A) CONTROLS


Device Classification Name

lipoprotein, low-density, antigen, antiserum, control

510(k) Number K023853
Device Name K-ASSAY LP(A) CONTROLS
Original Applicant
KAMIYA BIOMEDICAL CO.
910 industry dr.
seattle, 
WA 
98188 -3412

Original Contact brian schliesman
Regulation Number 866.5600
Classification Product Code
DFC  
Date Received 11/19/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls