ORTHO T. CRUZI ELISA TEST SYSTEM


Device Classification Name

enzyme linked immunosorbent assay, t. cruzi

510(k) Number K072732
Device Name ORTHO T. CRUZI ELISA TEST SYSTEM
Applicant
Ortho-Clinical Diagnostics, Inc.
1001 u.s. hwy. 202
raritan, 
NJ 
08869 -0606

Applicant Contact andrea j casper
Correspondent
Ortho-Clinical Diagnostics, Inc.
1001 u.s. hwy. 202
raritan, 
NJ 
08869 -0606

Correspodent Contact andrea j casper
Regulation Number 866.3870
Classification Product Code
MIU  
Date Received 09/26/2007
Decision Date 04/15/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No