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510(k) K981786

IGA MININEPH ANTISERUM by The Binding Site, Ltd. — Product Code CFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1999
Date Received
May 20, 1998
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

  • K990552 — IMMUNOGLOBULIN A TEST SYSTEM (March 25, 1999)
  • K990551 — IGG FLEX REAGENT CARTRIDGE (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)
  • 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)