IGLUCOSE SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K111932
Device Name IGLUCOSE SYSTEM
Applicant
POSITIVEID CORPORATION
1690 s. congress avenue
suite 200
delray beach, 
FL 
33445

Applicant Contact edward valdez
Correspondent
POSITIVEID CORPORATION
1690 s. congress avenue
suite 200
delray beach, 
FL 
33445

Correspodent Contact edward valdez
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 07/08/2011
Decision Date 11/10/2011
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