C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET


definition

Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K002651
Device Name C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
Original Applicant
POINTE SCIENTIFIC, INC.
1025 john a. papalas dr.
lincoln park, 
MI 
48146

Original Contact ron jamison
Regulation Number 866.5270
Classification Product Code
DCK  
Subsequent Product Code
JIS  
Date Received 08/25/2000
Decision Date 10/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No