GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF


Device Classification Name

giardia spp.

510(k) Number K081064
Device Name GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
Applicant
IVD RESEARCH, INC.
5470 e. edwin rd.
tucson, 
AZ 
85739

Applicant Contact michael wienholt
Correspondent
IVD RESEARCH, INC.
5470 e. edwin rd.
tucson, 
AZ 
85739

Correspodent Contact michael wienholt
Regulation Number 866.3220
Classification Product Code
MHI  
Date Received 04/14/2008
Decision Date 01/14/2009
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