IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE


Device Classification Name

enzymatic method, creatinine

510(k) Number K030035
Device Name IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
Original Applicant
DIAMETRICS MEDICAL, INC.
2658 patton rd.
saint paul, 
MN 
55113

Original Contact nancy ring
Regulation Number 862.1225
Classification Product Code
JFY  
Date Received 01/03/2003
Decision Date 06/25/2003
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