CRAG LATERAL FLOW ASSAY (LFA)


Device Classification Name

antisera, latex agglutination, cryptococcus neoformans

510(k) Number K112422
Device Name CRAG LATERAL FLOW ASSAY (LFA)
Applicant
IMMUNO-MYCOLOGICS, INC.
2700 technology place
norman, 
OK 
73071

Applicant Contact sean k bauman
Correspondent
IMMUNO-MYCOLOGICS, INC.
2700 technology place
norman, 
OK 
73071

Correspodent Contact sean k bauman
Regulation Number 866.3165
Classification Product Code
GMD  
Date Received 08/23/2011
Decision Date 03/28/2012
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