CONE-TROL HEMOGLOBIN A1C CONTROL SET


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K121534
Device Name CONE-TROL HEMOGLOBIN A1C CONTROL SET
Applicant
CONE BIOPRODUCTS
1012 n. austin st.
seguin, 
TX 
78155

Applicant Contact gail schievelbein
Correspondent
CONE BIOPRODUCTS
1012 n. austin st.
seguin, 
TX 
78155

Correspodent Contact gail schievelbein
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 05/24/2012
Decision Date 06/20/2012
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