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510(k) K950900

OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT by Olympus America, Inc. — Product Code CFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1995
Date Received
February 28, 1995
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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Other clearances for product code CFQ

  • K981786 — IGA MININEPH ANTISERUM (November 24, 1999)
  • K990551 — IGG FLEX REAGENT CARTRIDGE (March 25, 1999)
  • K990552 — IMMUNOGLOBULIN A TEST SYSTEM (March 25, 1999)
  • K990553 — IGM FLEX REAGENT CARTRIDGE (March 22, 1999)
  • K951013 — OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT (April 17, 1995)
  • K951055 — OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT (April 17, 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)