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510(k) K891188

TITAN GEL IFE TRIVALENT ANTISERUM by Helena Laboratories — Product Code CFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1989
Date Received
March 6, 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

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Other clearances for product code CFQ

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  • 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)
  • 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)