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510(k) K890561

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM by Atlantic Antibodies — Product Code CFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1989
Date Received
January 24, 1989
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

Other clearances by Atlantic Antibodies

  • K892526 — SPQ TM TEST SYSTEM II FOR CRP (May 9, 1989)
  • K891154 — SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B (March 16, 1989)
  • K890563 — SPQ(TM) ANTIBODY REAGENT SET II FOR TRF (March 3, 1989)
  • K890416 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGG (February 22, 1989)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K890564 — SPQ(TM) ANTIBODY REAGENT SET II FOR C4 (February 17, 1989)
  • K890417 — SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (February 17, 1989)
  • K890415 — SPQ(TM) ANTIBODY REAGENT SET II FOR AAT (February 17, 1989)
  • K890560 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGA (February 15, 1989)
  • K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (November 2, 1988)

Other clearances for product code CFQ

  • K981786 — IGA MININEPH ANTISERUM (November 24, 1999)
  • 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)
  • K881928 — MONOCLONAL RADIAL IMMUNODIFFUSION KIT (July 8, 1988)
  • K881827 — IMMUNOGLOBULIN A TEST SYSTEM (June 10, 1988)