K-ASSAY LP(A) ASSAY


Device Classification Name

lipoprotein, low-density, antigen, antiserum, control

510(k) Number K021660
Device Name K-ASSAY LP(A) ASSAY
Original Applicant
KAMIYA BIOMEDICAL CO.
910 industry dr.
seattle, 
WA 
98188 -3412

Original Contact brian schliesman
Regulation Number 866.5600
Classification Product Code
DFC  
Subsequent Product Code
JIS  
Date Received 05/20/2002
Decision Date 07/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No