Home / 510(k) Clearances / K112491

510(k) K112491

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 by Sebia — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2012
Date Received
August 29, 2011
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

Other clearances by Sebia

  • K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (April 4, 2024)
  • K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (February 23, 2024)
  • K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (November 18, 2022)
  • 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)
  • K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control (January 11, 2018)
  • K171537 — CAPI 3 Hb A1c (September 12, 2017)

Other clearances for product code GKA

  • K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (April 4, 2024)
  • 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)
  • K091283 — CAPILLARYS NEONAT HB (PN 2006) (February 22, 2010)
  • 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)