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510(k) K120169

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT by Grifols USA, LLC — Product Code CFF

K120169 is an FDA 510(k) premarket notification submitted by Grifols USA, LLC for the device "INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT". The FDA issued a decision of Substantially Equivalent on August 24, 2012. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Grifols USA, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2012
Date Received
January 19, 2012
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 Grifols USA, LLC

  • K113377 — GLIADIN IGA AND GLIADIN LGA (December 14, 2012)
  • K102964 — EU-TTG IGA AND EU-TTG IGG (March 7, 2011)

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)
  • 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)

FDA data resources