GLYCA-DIRECT FRUCTOSAMINE


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K023654
Device Name GLYCA-DIRECT FRUCTOSAMINE
Original Applicant
POLYMEDCO, INC.
510 furnace dock rd.
cortlandt manor, 
NY 
10567

Original Contact helen landicho
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 10/30/2002
Decision Date 05/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No