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510(k) K812327

KAPPA & LAMBDA BENCE JONES CONTROLS by Kallestad Laboratories, Inc. — Product Code CZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1981
Date Received
August 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bence-Jones Protein, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5150
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 CZQ

  • K802284 — ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. (October 23, 1980)