CALIBRATING MATERIAL, BUFFERS, STANDARD


Device Classification Name

calibrator, secondary

510(k) Number K022027
Device Name CALIBRATING MATERIAL, BUFFERS, STANDARD
Original Applicant
MISSION DIAGNOSTICS
331 fiske st.
holliston, 
MA 
01746

Original Contact linda stundtner
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 06/21/2002
Decision Date 07/22/2002
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