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510(k) K855014

QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A by Kallestad Laboratories, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
December 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Kallestad Laboratories, Inc.

  • K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM (December 3, 1986)
  • K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT (October 22, 1986)
  • 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)
  • 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)
  • K855008 — QUANTIMETRIC PLUS KAPPA REAGENT KIT (February 26, 1986)

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