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510(k) K143483

MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING by Sebia — Product Code CFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2015
Date Received
December 8, 2014
Clearance Type
Special
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

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  • 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 CFF

  • 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)
  • K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control (January 11, 2018)
  • K161928 — CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL (December 21, 2016)
  • 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)