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510(k) K203184

HYDRASHIFT 2/4 isatuximab by Sebia — Product Code CFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2021
Date Received
October 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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)
  • 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)
  • K162281 — CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (February 17, 2017)

Other clearances for product code CFF

  • K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera (November 1, 2019)
  • K190851 — HYDRASHIFT 2/4 daratumumab (May 2, 2019)
  • K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control (January 11, 2018)
  • K161928 — CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL (December 21, 2016)
  • K143483 — MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (January 8, 2015)
  • K120169 — INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT (August 24, 2012)
  • K111369 — THE HELENA V8 IMMUNODISPLACEMENT KIT (June 26, 2012)
  • K103757 — IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT (October 13, 2011)
  • K082085 — CAPILLARYS IMMUNOTYPING, MODEL 2100 (April 17, 2009)
  • K082388 — MINICAP IMMUNOTYPING, MODEL: 2300 (April 14, 2009)