K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K023828
Device Name K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
Original Applicant
KAMIYA BIOMEDICAL CO.
910 industry dr.
seattle, 
WA 
98188 -3412

Original Contact brian schliesman
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 11/18/2002
Decision Date 02/04/2003
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