LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA


Device Classification Name

calibrator, secondary

510(k) Number K033786
Device Name LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
Applicant
IBL GMBH
150 cherry lane rd.
east stroudsburg, 
PA 
18301

Applicant Contact gary lehnus
Correspondent
IBL GMBH
150 cherry lane rd.
east stroudsburg, 
PA 
18301

Correspodent Contact gary lehnus
Regulation Number 862.1150
Classification Product Code
JIT  
Subsequent Product Codes
CDZ   JJX  
Date Received 12/04/2003
Decision Date 02/27/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No