ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K022176
Device Name ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
Original Applicant
ORION DIAGNOSTICA, DIV. ORION CORP.
koivu-mankkaan tie 6
espoo, 

FI

02200

Original Contact annikka rantama
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 07/03/2002
Decision Date 12/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No