WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET


Device Classification Name

calibrator, primary

510(k) Number K030320
Device Name WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
Original Applicant
WAKO CHEMICALS, USA, INC.
1600 bellwood road
richmond, 
VA 
23237

Original Contact lori creasy
Regulation Number 862.1150
Classification Product Code
JIS  
Subsequent Product Codes
JIQ   JJX  
Date Received 01/30/2003
Decision Date 04/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No