IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT


Device Classification Name

immunoelectrophoretic, immunoglobulins, (g, a, m)

510(k) Number K103757
Device Name IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
Applicant
GRIFOLS
150 cherry lane road
east stroudsburg, 
PA 
18301

Applicant Contact gary lehnus
Correspondent
GRIFOLS
150 cherry lane road
east stroudsburg, 
PA 
18301

Correspodent Contact gary lehnus
Regulation Number 866.5510
Classification Product Code
CFF  
Subsequent Product Codes
CEF   DEH   DFH  
Date Received 12/23/2010
Decision Date 10/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No