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510(k) K854483

KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT by Kallestad Laboratories, Inc. — Product Code KTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1985
Date Received
November 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Immunoassay, Igg
Device Class
Class I
Regulation Number
866.5530
Review Panel
IM
Submission Type

Other clearances by Kallestad Laboratories, Inc.

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  • K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT (October 10, 1986)
  • K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (September 29, 1986)
  • K862313 — KALLESTAD SM/RNP TEST REAGENT (August 6, 1986)
  • K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS (July 29, 1986)
  • K855014 — QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (March 14, 1986)
  • K855010 — QUANTIMETRIC PLUS IGM REAGENT KIT (February 28, 1986)
  • K855012 — QUANTIMETRIC PLUS C4 REAGENT KIT (February 26, 1986)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)

Other clearances for product code KTO

  • K894416 — RAICHEM(TM) SPIA(TM) IGG REAGENTS (August 1, 1989)