RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K081478
Device Name RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
Applicant
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01434

Applicant Contact kathleen storro
Correspondent
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01434

Correspodent Contact kathleen storro
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 05/27/2008
Decision Date 10/06/2008
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