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FDA 510(k), K051072, BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
FDA 510(k), K051072, BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
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510(K) Number: K051072
Device Name: BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
Manufacturer: WILLIAM G GUSTAFSON
Device Classification Name: Abnormal Hemoglobin Quantitation
Regulation Number: GKA
Classification Product Code: 04/26/2005
Date Received: 05/12/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
Manufacturer: WILLIAM G GUSTAFSON
Device Classification Name: Abnormal Hemoglobin Quantitation
Regulation Number: GKA
Classification Product Code: 04/26/2005
Date Received: 05/12/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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