BINAXNOW G6PD TEST


Device Classification Name

glucose-6-phosphate dehydrogenase (erythrocytic), screening

510(k) Number K080003
Device Name BINAXNOW G6PD TEST
Applicant
BINAX, INC.
10 southgate rd.
scarborough, 
ME 
04074

Applicant Contact anne jepson
Correspondent
BINAX, INC.
10 southgate rd.
scarborough, 
ME 
04074

Correspodent Contact anne jepson
Regulation Number 864.7360
Classification Product Code
JBF  
Date Received 01/02/2008
Decision Date 10/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No