I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE


Device Classification Name

acid, lactic, enzymatic method

510(k) Number K112430
Device Name I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
Applicant
ABBOTT PONT OF CARE INC
400 college road east
princeton, 
NJ 
08540

Applicant Contact yuko hartley
Correspondent
ABBOTT PONT OF CARE INC
400 college road east
princeton, 
NJ 
08540

Correspodent Contact yuko hartley
Regulation Number 862.1450
Classification Product Code
KHP  
Date Received 08/24/2011
Decision Date 12/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No