Home / 510(k) Clearances / K103757

510(k) K103757

IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT by Grifols — Product Code CFF

K103757 is an FDA 510(k) premarket notification submitted by Grifols for the device "IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT". The FDA issued a decision of Substantially Equivalent on October 13, 2011. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2011
Date Received
December 23, 2010
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 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)
  • 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)
  • K082085 — CAPILLARYS IMMUNOTYPING, MODEL 2100 (April 17, 2009)
  • K082388 — MINICAP IMMUNOTYPING, MODEL: 2300 (April 14, 2009)

FDA data resources