V8 SP NORMAL CONTROL, ABNORMAL CONTROL

Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K131479
Device Name V8 SP NORMAL CONTROL, ABNORMAL CONTROL
Applicant
HELENA LABORATORIES
1530 lindbergh dr.
beaumont, 
TX 
77704

Applicant Contact justin padia
Correspondent
HELENA LABORATORIES
1530 lindbergh dr.
beaumont, 
TX 
77704

Correspodent Contact justin padia
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 05/22/2013
Decision Date 10/07/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No