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510(k) K024162

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 by Helena Laboratories — Product Code CFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2003
Date Received
December 17, 2002
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

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  • 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)