DROPPER A1C DIABETES CONTROL


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K103744
Device Name DROPPER A1C DIABETES CONTROL
Applicant
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach, 
CA 
90278 -1205

Applicant Contact kalyna snylyk
Correspondent
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach, 
CA 
90278 -1205

Correspodent Contact kalyna snylyk
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 12/23/2010
Decision Date 05/12/2011
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