ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011


Device Classification Name

radioimmunoassay, acth

510(k) Number K050748
Device Name ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
Applicant
SCANTIBODIES LABORATORY, INC.
9336 abraham way
santee, 
CA 
92071

Applicant Contact michael nordstrom
Correspondent
SCANTIBODIES LABORATORY, INC.
9336 abraham way
santee, 
CA 
92071

Correspodent Contact michael nordstrom
Regulation Number 862.1025
Classification Product Code
CKG  
Date Received 03/22/2005
Decision Date 05/20/2005
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