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510(k) K855011

QUANTIMETRIC PLUS C3 REAGENT KIT by Kallestad Laboratories, Inc. — Product Code CZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1986
Date Received
December 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iga, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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)
  • 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 CZN

  • K891683 — TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (April 12, 1989)
  • K841815 — OPTIMATE IGA TEST (June 1, 1984)
  • K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (October 31, 1983)
  • K832257 — GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (October 28, 1983)
  • K831909 — RABBIT ANTISERUM TO HUMAN IGA (July 18, 1983)
  • K831607 — FIAX IGA TEST KIT (June 22, 1983)