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510(k) K091283

CAPILLARYS NEONAT HB (PN 2006) by Sebia — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2010
Date Received
May 1, 2009
Clearance Type
Traditional
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

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  • K203184 — HYDRASHIFT 2/4 isatuximab (November 12, 2021)
  • K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera (November 1, 2019)
  • K190851 — HYDRASHIFT 2/4 daratumumab (May 2, 2019)
  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171861 — CAPILLARYS Hb A1c (February 7, 2018)
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Other clearances for product code GKA

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  • K222635 — Premier Resolution System (August 4, 2023)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • K112550 — CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (May 25, 2012)
  • K112491 — SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (May 24, 2012)
  • K082227 — MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (March 26, 2009)
  • K080911 — VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTE (May 2, 2008)
  • K052291 — CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (June 27, 2006)