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FDA 510(k), K080911, VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
FDA 510(k), K080911, VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
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510(K) Number: K080911
Device Name: VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
Manufacturer: J.B BARTILSON
Device Classification Name: Abnormal Hemoglobin Quantitation
Regulation Number: GKA
Classification Product Code: 04/02/2008
Date Received: 05/02/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
Manufacturer: J.B BARTILSON
Device Classification Name: Abnormal Hemoglobin Quantitation
Regulation Number: GKA
Classification Product Code: 04/02/2008
Date Received: 05/02/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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