QUANTA LITE OMP PLUS ELISA


Device Classification Name

antibodies, outer-membrane proteins

510(k) Number K081248
Device Name QUANTA LITE OMP PLUS ELISA
Applicant
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

Applicant Contact zakera shums
Correspondent
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

Correspodent Contact zakera shums
Regulation Number 866.5785
Classification Product Code
OKM  
Date Received 05/02/2008
Decision Date 10/27/2008
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