RDI HS CRP CALIBRATOR SET


Device Classification Name

calibrator, secondary

510(k) Number K021607
Device Name RDI HS CRP CALIBRATOR SET
Original Applicant
REFERENCE DIAGNOSTICS, INC.
19 crosby dr. suite 30
bedford, 
MA 
01730

Original Contact joseph lawlor
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 05/16/2002
Decision Date 06/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No