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510(k) K780250

HEMOPEXIN NEPHELOMETRIC ASSAYS by Kallestad Laboratories, Inc. — Product Code CZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1978
Date Received
February 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemopexin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5490
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 CZX

  • K801432 — HEMOPEXIN NEPHELOMETRIC ASSAY (July 8, 1980)
  • K790713 — ANTISERUM TO HUMAN HEMOPEXIN (September 4, 1979)