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510(k) K080911

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH by Bio-Rad Laboratories Inc., Clinical Systems Divisi — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
April 2, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

Other clearances by Bio-Rad Laboratories Inc., Clinical Systems Divisi

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  • K063643 — MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGR (December 27, 2006)

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  • K052291 — CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (June 27, 2006)