VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH


Device Classification Name

abnormal hemoglobin quantitation

510(k) Number K080911
Device Name VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
Applicant
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
4000 alfred nobel dr.
hercules, 
CA 
94547

Applicant Contact j.b bartilson
Correspondent
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
4000 alfred nobel dr.
hercules, 
CA 
94547

Correspodent Contact j.b bartilson
Regulation Number 864.7415
Classification Product Code
GKA  
Date Received 04/02/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No