WAKO NEFA LINEARITY SET


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K030065
Device Name WAKO NEFA LINEARITY SET
Original Applicant
WAKO CHEMICALS, USA, INC.
1600 bellwood road
richmond, 
VA 
23237

Original Contact tonya mallory
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 01/07/2003
Decision Date 02/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Toxicology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No