Home / 510(k) Clearances / K811740

510(k) K811740

KALLESTAD'S ENDOPLATE FACTOR B TEST by Kallestad Laboratories, Inc. — Product Code JZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1981
Date Received
June 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Factor B, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5320
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 JZH

  • K964843 — IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT (March 6, 1997)
  • K882623 — PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (July 8, 1988)
  • K831959 — RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (July 19, 1983)
  • K781016 — C3PA (GBG) PROPERDIN FACTOR B (August 14, 1978)
  • K772084 — LAS-R HUMAN C3 PROACTIVATOR TEST (January 24, 1978)