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510(k) K990551

IGG FLEX REAGENT CARTRIDGE by Dade Behring, Inc. — Product Code CFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1999
Date Received
February 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code CFQ

  • K981786 — IGA MININEPH ANTISERUM (November 24, 1999)
  • K990552 — IMMUNOGLOBULIN A TEST SYSTEM (March 25, 1999)
  • K990553 — IGM FLEX REAGENT CARTRIDGE (March 22, 1999)
  • K951055 — OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT (April 17, 1995)
  • K951013 — OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT (April 17, 1995)
  • K950900 — OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT (March 27, 1995)
  • K891188 — TITAN GEL IFE TRIVALENT ANTISERUM (March 22, 1989)
  • K890561 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (February 23, 1989)
  • K881928 — MONOCLONAL RADIAL IMMUNODIFFUSION KIT (July 8, 1988)
  • K881827 — IMMUNOGLOBULIN A TEST SYSTEM (June 10, 1988)